[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteosarcoma":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,68,0,25,[9,50,80,103,130,164,188,211,242,263,288,319,343,364,390,418,447,465,486,508,531,553,581,660,692],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100054232","phase-1-trastuzumab-deruxtecan-ds-8201a-for-the-treatment-of-newly-diagnosed-recurrent-or-refractory-osteosarcoma-wilms-tumor-and-desmoplastic-small-round-cell-tumor-100054232",false,"NCT04616560","Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Newly Diagnosed, Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","A Phase 1\u002F2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","Inclusion Criteria:\n\n* Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment\n* Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment\n\n  * Until the completion of the Phase 1 dose confirmation, patients must be at least 12 years of age and less than 18 years of age at the time of study enrollment\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, Wilms tumor patients at least 2 to less than 18 years of age will be allowed on the Phase 2 component\n* Phase 2: DSRCT patients (Part B2): Until the completion of the Phase 1 component, patients enrolling on the Phase 2 component of the study must be from at least 12 to 39 years of age at the time of study enrollment\n\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, DSRCT patients at least 2 to 39 years of age will be allowed on the Phase 2 component\n* Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse\n* Solid tumors: Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Lastly, patient must have unresectable lesions or lesions with no intention to surgically remove the lesions in the 6 months following enrollment\n* Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:\n\n  * Relapse after initial treatment with 4 or more chemotherapy agents (e.g. Regimens vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide and radiation \\[M\\], vincristine, dactinomycin and doxorubicin, vincristine, and irinotecan \\[MVI\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide and radiation \\[UH-1\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide, vincristine, and irinotecan \\[UH-2\\], vincristine, irinotecan, cyclophosphamide, carboplatin, etoposide and doxorubicin \\[UH-3\\], and etoposide, carboplatin, cyclophosphamide, and doxorubicin \\[HR-1\\])\n  * Relapse with high risk histology (anaplasia, blastemal predominant)\n  * Multiple relapses\n* Desmoplastic small round cell tumor: DSRCT patients with relapsed or refractory disease are eligible\n* Patient's current disease state must be one for which they have received at least standard initial therapy, defined as systemic therapy combined with either radiation or surgery for local control of the primary tumor at diagnosis. Prior therapy after relapse is not required\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1. Use Karnofsky for patients older than 16 years of age and Lansky for patients 16 years of age and younger\n* Patients must have recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment\n\n    * \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 4 weeks (28 days) must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\\u003C 1\n  * Corticosteroids\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 30 days after the completion the infusion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy (XRT)\u002Fexternal beam irradiation including protons: \\>= 4 weeks (28 days) including palliative radiation therapy to the chest. \\>= 14 days after palliative local XRT to areas other than the chest or for whole brain radiotherapy\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, samarium): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior HER2 therapies including antibody drug conjugates (e.g. TDM-1 or DS-8201a), HER2 directed cellular therapies, HER2 receptor therapy (e.g. trastuzumab, pertuzumab, margetuximab, zanidatamab, zenocutuzumab) or small molecule antagonists of HER2 (e.g lapatinib, tucatinib, or neratinib). Prior exposure to antibody drug conjugates which do not target HER2 as well as prior treatment with topoisomerase 1 inhibitors (e.g. irinotecan, topotecan) are permitted\n* Patients must be at least 14 days from the date of last surgery\n* Peripheral absolute neutrophil count (ANC) \\>= 1000\u002FuL, (for patients with solid tumors without known bone marrow involvement)\n* Platelet count \\>= 100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* Hemoglobin \\>= 8.0 g\u002FdL at baseline (Red Blood Cell transfusion is not allowed within 1 week prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* For patients less than or equal to 17 years old, \"Bedside\" Schwartz formula (2009)\n* Estimated glomerular filtration rate (GFR) (eGFR) ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 (\\> 70mL\u002Fmin\u002F1.73 m\\^2 for patients \\> 17 years old)\n\n  * For patients older than 17 years of age the Cockroft-Gault equation should be utilized to calculate creatinine clearance ≥ 70 ml\u002Fmin:\n  * OR for any age group:\n\n    * A 24 hour urine creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m\\^2 (\\> 70mL\u002Fmin for patients ≥ 17 years old) OR\n    * A directly measured GFR ≥ 70 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n* Bilirubin (sum of conjugated + unconjugated or total) =\\\u003C 1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) bilirubin must be \\\u003C 3 x ULN for age (patients with solid tumors)\n* Aspartate aminotransferase (AST) =\\\u003C 3 x ULN\n* Serum albumin \\>= 2.5 g\u002FdL (patients with solid tumors)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) =\\\u003C 1.5 x ULN. Exception for patients receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have INR\u002FPT within the therapeutic range as deemed appropriate by the investigator\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before Step 1 enrollment\n* Corrected QT interval (QTc) prolongation to \\\u003C 480 ms based on average triplicate 12-lead electrocardiogram (ECG)\n* Pulse oximetry \\> 93% on room air\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior chemotherapy, surgery, and\u002For radiation must be =\\\u003C grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible\n* All patients and\u002For their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant, or breast-feeding women will not be entered on this study. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Abstinence is an acceptable method of birth control\n\n  * Methods considered as highly effective methods of contraception include:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Intravaginal\n      * Transdermal\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Injectable\n      * Implantable\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Complete sexual abstinence defined as refraining from heterosexual intercourse. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception\n* Non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at enrollment and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving chloroquine or hydroxychloroquine within 14 days are not eligible for this trial\n* Patients who received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to enrollment are not eligible for this trial\n\n  * Note: Participants, if enrolled, should not receive live vaccines during the study and up to 90 days after the last dose of study intervention. It is recommended that patients receive a yearly influenza killed vaccination and additional killed vaccinations based on local or national recommendations. Consider vaccination against viral pathogens that cause pneumonias according to local or national guidelines\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients with a medical history of myocardial infarction within 180 days before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) or troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment are not eligible\n* Additionally, patients with a history of any of the following congenital heart disease are not eligible:\n\n  * Single ventricle heart defects (hypoplastic left heart syndrome, unbalanced atrioventricular septal defects, double inlet left ventricle, tricuspid atresia, the presence of superior cavopulmonary anastomosis or Fontan palliation);\n  * Unpalliated defects with significant hemodynamic alterations or palliated lesions with residual hemodynamic alterations (ductal-dependent or shunt-dependent physiology, large unrestrictive ventricular septal defect, transposition of the great arteries, greater than moderate atrioventricular valve insufficiency, moderate or greater aortic valve stenosis, moderate or greater aortic valve insufficiency, large atrial septal defects with significant right ventricular volume overload, large patent ductus arteriosus)\n* Patients who have a pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART) are not eligible. (Drainage and concentrated ascites reinfusion therapy are not allowed within 2 weeks prior to enrollment)\n* Patients who have spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms are not eligible\n* Patients with a known history of severe hypersensitivity to DS-8201a, any excipient contained in the DS-8201a drug formulation, or HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab, margetuximab) are not eligible\n* Patients who have an uncontrolled infection or non-healing surgical site are not eligible\n* Patients with a known history of substance abuse or any other clinically significant medical conditions (i.e. psychological conditions) that may, in the opinion of the investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results are not eligible\n* Patients who have pulmonary compromise, ex hypoxia, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), or prior pneumonectomy are not eligible\n* Patients who have a history of (non-infectious) ILD (interstitial lung disease)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or for whom suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening are not eligible. Patients who have history of genetic disorders of the lung (i.e. cystic fibrosis are not eligible)\n* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Patients with known hepatitis B or C with detectable viral load are not eligible\n* Patients with any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of enrollment or genetic diseases involving the lung are not eligible\n* Patients with an active primary immunodeficiency are not eligible","ALL","12 Years","39 Years",{"count":21,"type":22},55,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This phase I\u002FII trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.",[29,30,31,32,33,34,35,36],"Desmoplastic Small Round Cell Tumor","Osteosarcoma","Recurrent Desmoplastic Small Round Cell Tumor","Recurrent Kidney Wilms Tumor","Recurrent Osteosarcoma","Refractory Desmoplastic Small Round Cell Tumor","Refractory Wilms Tumor","Wilms Tumor","RECRUITING","2026-07-10",{"date":40,"type":41},"2026-07-13","ACTUAL",{"date":43,"type":41},"2021-03-08",{"date":45,"type":22},"2027-12-31",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",28,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100632525","integration-of-adaptive-proton-therapy-in-pediatric-solid-tumors-and-hodgkins-lymphoma-100632525","NCT07514819","Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma","Inclusion Criteria:\n\n* Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.\n* Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.\n* Research participant or legal guardian\u002Frepresentative gives written informed consent.\n\nExclusion Criteria:\n\n* Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.\n* Participants who are diagnosed with Wilm's tumor or neuroblastoma\n* Participants who do not undergo proton therapy.\n* Participants who are prescribed equal or less than 5 fractions of proton therapy.\n* Participants with severe comorbid conditions that may impact imaging feasibility.\n* Inability to obtain written consent from research participant or legal guardian\u002Frepresentative.\n* Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants \\>10 years of age or post-menarchal must have a negative serum or urine pregnancy test\n\nAll participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.",{"count":57,"type":22},100,[59],"NA","Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.\n\nPrimary Objective:\n\n* Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.\n* Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.\n\nSecondary Objectives\n\n* Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.\n* Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.",[62,63,64,30,65,66,67],"Pediatric Solid Tumors","Rhabdomyosarcoma","Ewing Sarcoma","Hodgkin Lymphoma","Bone Tumor","Soft Tissue Sarcoma","NOT_YET_RECRUITING","2026-06-30",{"date":71,"type":41},"2026-07-02",{"date":73,"type":22},"2026-08",{"date":75,"type":22},"2031-08",{"name":77,"class":78},"St. Jude Children's Research Hospital","OTHER",1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100557680","phase-1-silmitasertib-cx-4945-in-combination-with-chemotherapy-for-relapsed-refractory-solid-tumors-100557680","NCT06541262","Silmitasertib (CX-4945) in Combination With Chemotherapy for Relapsed Refractory Solid Tumors","Phase I\u002FII Study of Silmitasertib (CX-4945) in Combination With Chemotherapy in Children and Young Adults With Relapsed Refractory Solid Tumors","Inclusion Criteria:\n\n1. Age: Less than 30 years old at initial diagnosis\n2. Pathology All subjects must have a confirmed diagnosis of tumor type. Phase I: Relapsed\u002Frefractory solid tumors: Neuroblastoma, Ewing Sarcoma, Osteosarcoma, Rhabdomyosarcoma, Liposarcoma\n\n   Phase II:\n   * Relapsed\u002Frefractory Neuroblastoma\n   * Relapsed\u002Frefractory Ewing sarcoma\n3. Tumor assessment:\n\n   Disease assessment is required for eligibility and must be done after last dose of previous therapy and prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed\u002FRefractory Neuroblastoma Relapsed disease defined as neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol) and has now relapsed and is in any number of relapses.\n\n   Refractory disease defined as High-risk neuroblastoma (as defined by INRG) that failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy, progression during upfront therapy or with disease remaining after standard immunotherapy.\n\n   International Neuroblastoma Risk Group Staging System (INRG) High Risk NB defined as one of the following:\n   1. Any age with International Neuroblastoma Risk Group (INRG) Stage L2, MS, or M with MYCN amplification\n   2. Age ≥ 547 days and INRG Stage M regardless of biologic features\n   3. Any age initially diagnosed with INRG Stage L1 MYCN amplified NBL who have progressed to Stage M without systemic chemotherapy\n   4. Age ≥ 547 days of age initially diagnosed with INRG Stage L1, L2, or MS who have progressed to Stage M without systemic chemotherapy\n\n   Relapsed\u002Frefractory Sarcoma Subjects that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for sarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n5. Measurable or evaluable disease, including at least one of the following:\n\n   * Measurable tumor by CT or MRI\n   * MIBG or PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n6. Timing from prior therapy:\n\n   Subjects must have fully recovered from the acute toxic effects of all prior anti- cancer therapy and be within the following timelines:\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study.\n   2. Small Molecule Inhibitors (anti-neoplastic agent): At least 2 weeks from the completion of therapy with a small molecule inhibitor.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells, anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.).\n   4. Radiotherapy: At least 30 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n   5. Stem Cell Transplant:\n\n      * Allogeneic: No evidence of active graft vs. host disease\n      * Allogeneic\u002FAutologous: ≥ 2 months must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n7. Subjects must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 50.\n8. Subjects must have adequate organ function at the time of enrollment:\n\n   * Cardiac: Subjects must have a QTcF ≤ 480 msc.\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C5x upper limit of normal\n   * Renal: Subjects must have adequate renal function defined as:\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (for subjects \\\u003C 17 years old) (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (for subjects ≥17 years old (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n9. Subjects of childbearing potential must have a negative serum pregnancy test. Subjects of childbearing potential must agree to use effective measures to avoid pregnancy.\n10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all subjects (or subjects' legal representative).\n\nExclusion Criteria:\n\n1. Investigational Drugs: Subjects who are currently receiving another investigational drug are excluded from participation.\n2. Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the hematological and bone marrow suppression effects of prior therapy.\n3. Subjects who are currently receiving Vitamin K antagonists (warfarin).\n4. Subjects who are currently receiving the class of lipid-lowering medications HMG-CoA reductase inhibitors (statins).\n5. Infection: Subjects who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n7. Subjects with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the subject's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n8. Subjects with any of the following gastrointestinal disorders:\n\n   1. Active malabsorption (e.g. short gut) syndrome.\n   2. Uncontrolled diarrhea (excess of 4 stools\u002Fday)\n   3. Gastritis, ulcerative colitis, Chron's disease or hemorrhagic coloproctitis\n   4. History of gastric or small bowel surgery involving any extent of gastric or small bowel resection\n9. Lactating subjects are not eligible unless they have agreed to not breastfeed their infants. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the nursing subject with silmitasertib. (NOTE: breast milk cannot be stored for future use while the nursing subject is being treated on study.)\n10. Subjects with a history of any other malignancy.","30 Years",{"count":89,"type":22},104,[25,26],"The purpose of this study is to evaluate the investigational drug, silmitasertib (a pill taken by mouth), in combination with FDA approved drugs for solid tumors. An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of silmitasertib in combination with chemotherapy\n* Test the safety and tolerability of silmitasertib in combination with chemotherapy in subjects with cancer\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[93,64,30,63,94],"Neuroblastoma","Liposarcoma",{"date":71,"type":41},{"date":97,"type":41},"2024-10-30",{"date":99,"type":22},"2035-11-01",{"name":101,"class":78},"Milton S. Hershey Medical Center",22,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100551831","phase-1-eflornithine-dfmo-and-amxt-1501-for-neuroblastoma-cns-tumors-and-sarcomas-100551831","NCT06465199","Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and Sarcomas","A Phase I\u002FII Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas","Inclusion Criteria:\n\n1. Age:\n\n   All participants : Must be a maximum of 26 years of age at diagnosis\n\n   Age at enrollment by Phase:\n   1. Safety Run-in (Dose level 1)-The first three (3) participants enrolled will be ≥ 12 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the next three (3) participants enrolled who will be ≥6 years of age at enrollment. Once evaluated for safety by DSMB, we will move on to the Phase I.\n   2. Phase I and II: ≤ 26 years of age at diagnosis.\n2. Pathology\n\n   All participants must have a confirmed pathologic diagnosis of tumor type (except for DIPG):\n   * Relapsed\u002Frefractory Neuroblastoma (NB)\n   * Relapsed\u002Frefractory Embryonal tumor with multilayer rosettes (ETMR)\n   * Relapsed\u002Frefractory Atypical teratoid rhabdoid tumor (ATRT)\n   * Newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)- radiologic diagnosis acceptable\n   * Relapsed\u002Frefractory Ewing Sarcoma (EWS)\n   * Relapsed\u002Frefractory Osteosarcoma (OST)\n3. Tumor assessment:\n\n   Disease staging must be performed at baseline during the 28 day screening period prior to first dose of study drug.\n4. Disease Status:\n\n   Relapsed or Refractory Neuroblastoma Relapsed disease defined as: High-risk neuroblastoma that was previously in remission after standard therapy (at least 4 cycles of aggressive multi-drug induction chemotherapy, with or without radiation, surgery, and immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol).\n\n   Refractory disease defined as: High-risk neuroblastoma that 1) failed to achieve CR after at least 4 cycles of aggressive multi-drug induction chemotherapy with or without radiation and surgery, followed by immunotherapy, or according to a standard high-risk treatment\u002Fneuroblastoma protocol, or 2) progression during upfront therapy or 3) with disease remaining after standard immunotherapy.\n\n   Eligible NB participants may have active disease or no active disease.\n\n   NB participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   NB participants with active disease need to meet the following criteria:\n   * Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n   * Participants must not have disease in any organs (including lungs, liver, or brain).\n\n   Relapsed or refractory ETMR\u002FATRT Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive\u002Fprogressive to accepted curative therapy, including up-front chemotherapy and radiation and\u002For high-dose chemotherapy with stem cell rescue.\n\n   ETMR\u002FATRT participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   ETMR\u002FATRT participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n\n   Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) Participants with DIPG to start greater than 30 days, and no longer than 60 days, after standard of care radiation therapy.\n\n   Participants with newly-diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of the pons on at least 1 axial T2-weighted image, are eligible. No histologic confirmation is required. Participants with metastatic disease are not eligible. Participants with a biopsy and no evidence of H3K27m mutations are eligible as long as they meet radiographic criteria. Participants with H3K27m altered DMG outside of the brainstem are not eligible. Participants with progression or recurrence after initial standard of care radiation are ineligible.\n\n   Relapsed or refractory Ewing sarcoma and osteosarcoma Participants that have relapsed following standard of care therapy or having progressed during standard of care therapy. Standard of care therapy for Ewing sarcoma and osteosarcoma includes multi-agent chemotherapy with local control consisting of either surgery or radiation therapy.\n\n   EWS\u002FOST Participants with no active disease need to meet the following criteria:\n\n   Timing from prior therapy: Enrollment (first dose of study drug) no later than 60 days from most recent therapy.\n\n   EWS\u002FOST Participants with active disease need to meet the following criteria:\n\n   • Received at least one recent treatment for their relapse\u002Frefractory disease and is stable (SD) or better on this treatment.\n5. Participants must be able to swallow capsules.\n6. Participants with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week and must not have progressive hydrocephalus at enrollment.\n7. Participants must have fully recovered from the acute toxic effects of all prior anti- cancer chemotherapy and be within the following timelines:\n\n   1. Myelosuppressive chemotherapy: Must not have received within 2 weeks of enrollment onto this study (6 weeks if prior nitrosourea).\n   2. Small Molecule Inhibitor (anti-neoplastic agent): At least 7 days since the completion of therapy with a small molecule inhibitor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the Study Chair.\n   3. Immunotherapy: At least 4 weeks since the completion of any type of immunotherapy, e.g. tumor vaccines, CAR-T cells except for anti-GD2 Monoclonal antibodies (ex. naxitamab, dinutuximab, etc.) which should be at least 2 weeks since prior treatment with a monoclonal antibody.\n   4. XRT: At least 14 days since the last treatment except for radiation delivered with palliative intent to a non-target site.\n\n      Note: Participants with DIPG will be required to have had up front standard of care radiation. As above, participants with DIPG must be between 30-60 days post initial up- front radiation therapy.\n   5. Stem Cell Transplant:\n\n      1. Allogeneic: No evidence of active graft vs. host disease\n      2. Allo\u002FAuto: ≥ 45 days must have elapsed since transplant.\n   6. MIBG Therapy: At least 6 weeks since treatment with MIBG therapy.\n8. Participants must have a Lansky or Karnofsky Performance Scale score of \\>\u002F= 60\n9. Participants must have adequate organ function at the time of enrollment:\n\n   * Hematological: Hematological recovery as defined by ANC ≥750\u002FμL (unsupported- \\>24 hrs off G-CSF and 7 days off neulasta)\n   * Liver: Adequate liver function as defined by AST and ALT \\\u003C10x upper limit of normal\n   * Cardiac: all participants must have:\n\n     1. Normal serum Cardiac Troponin Concentration\n     2. Normal BNP (B-type natriuretic peptide) Level\n     3. A QTcF ≤ 470 msec (or EKG with no significant findings)\n     4. Normal ECHO defined as:\n\n     i. Shortening fraction of ≥ 27% by echocardiogram, or ii. Ejection fraction of ≥ 50% by echocardiogram or radionuclide angiogram\n   * Renal: Participants must have adequate renal function defined as:\n\n     1. For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     2. For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n10. Participants of childbearing potential must have a negative pregnancy test. Participants of childbearing potential must agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n11. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.","26 Years",{"count":112,"type":22},289,[25,26],"The purpose of this study is to evaluate the investigational oral drug AMXT 1501 in combination with oral eflornithine (DFMO). An investigational drug is one that has not been approved by the U.S. Food \\& Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.\n\nThe goals of this part of the study are:\n\n* Establish a recommended dose of AMXT 1501 in combination with DFMO\n* Test the safety and tolerability of AMXT 1501 in combination with DFMO\n* To determine the activity of study treatments chosen based on:\n* How each subject responds to the study treatment\n* How long a subject lives without their disease returning\u002Fprogressing",[116,117,64,118,30,93,119],"Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Diffuse Intrinsic Pontine Glioma","DIPG Brain Tumor",[121],"DFMO",{"date":123,"type":41},"2026-07-01",{"date":125,"type":41},"2026-05-13",{"date":127,"type":22},"2035-05",{"name":101,"class":78},12,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":137,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":152,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":79},"100564132","phase-1-alphabeta-t-and-b-cell-depletion-with-zoledronic-acid-for-solid-tumors-100564132","NCT06625190","Alpha\u002FBeta T and B Cell Depletion With Zoledronic Acid for Solid Tumors","Allogeneic Stem Cell Transplantation Utilizing Alpha\u002FBeta T Cell and CD19+ B Cell Depletion With Zoledronic Acid in Combination to Treat Pediatric, Adolescent, and Young Adult Patients With Relapsed\u002FRefractory Solid Tumors","Inclusion Criteria:\n\n* Patients 6 months to ≤ 25 years old\n* Relapsed\u002FRefractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \\>20% chance of cure with the following diseases:\n\n  1. neuroblastoma (high risk with relapsed or refractory disease),\n  2. relapsed\u002Frefractory rhabdomyosarcoma,\n  3. relapsed\u002Frefractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),\n  4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,\n  5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor\n  6. relapsed\u002Frefractory bone tumors: osteosarcoma and Ewing sarcoma\u002FPNET, or\n  7. Wilm's tumor or other high-risk solid tumors with \\\u003C10% expected survival with conventional treatment.\n* Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \\[as determined by the treating physician and approved by the PI\\] may be included.)\n* Haplo-identical related donor (at least one full haplotype must be matched).\n* Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \\>16 years of age and Lansky scores for patients ≤16 years of age\n* Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:\n\n  1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen.\n  2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL\u002Fmin\u002F1.73 m2 or a serum creatinine based on age\u002Fgender\n  3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA).\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures\n* Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.\n* Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.\n\nExclusion Criteria:\n\n* Patients with documented uncontrolled infection at the time of study entry are not eligible.\n\n  a. Uncontrolled infection is patient without treatment antimicrobials and\u002For demonstrating progression despite antimicrobials\n* Patients with progressive solid tumor disease after relapsed\u002Frefractory treatment.\n* Demonstrated lack of compliance with medical care, as determined by the treating physician.\n* Patients who have received an allogeneic HSCT within 6 months.\n* Patients who do not have an eligible allogeneic donor available.\n* Patients with a life expectancy \\\u003C3 months\n* Patients not meeting inclusion criteria for organ function.\n* Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.\n* Females who are known to be pregnant or breastfeeding.\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","6 Months","25 Years",{"count":140,"type":22},27,[25,26],"Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.\n\nWhile solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.\n\nBy utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed\u002Frefractory solid tumors and promote an improved event-free survival and overall survival.\n\nThis study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.",[93,63,144,145,146,147,29,148,149,150,151,30,64,36],"Synovial Sarcoma","Peripheral Nerve Sheath Tumors","Clear Cell Sarcoma","Alveolar Soft Part Sarcoma","Chordoma","Rhabdoid Tumor","Epithelioid Sarcoma","Myoepithelial Tumor",[153,154,155],"pediatric solid tumors","stem cell transplantation","graft manipulation","2026-06-25",{"date":69,"type":41},{"date":159,"type":41},"2026-02-11",{"date":161,"type":22},"2030-02",{"name":163,"class":78},"University of Florida",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":79},"100641897","phase-1-tumor-neoantigen-vaccine-sarvac-combined-with-tumor-specific-lymphocyte-reinfusion-in-the-treatment-of-advanced-sarcoma-100641897","NCT07648069","Tumor Neoantigen Vaccine SarVac Combined With Tumor Specific Lymphocyte Reinfusion in the Treatment of Advanced Sarcoma","A Prospective, Single-center, Double-arm, Phase I Clinical Trial of Tumor Neoantigen Vaccine SarVac Combined With Tumor-specific Lymphocyte Reinfusion in the Treatment of Patients With Advanced or Unresectable Sarcoma-based Solid Tumors Who Failed Standard Treatment.","Inclusion Criteria:\n\n1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n2. Age≥18 years old, and≤70 years old ;\n3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ;\n4. Patients with first-line treatment failure ;\n5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ;\n6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ;\n7. The following three screening indicators should be met in the test screening period:\n\n（1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.\n\n( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n* 1\\. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n\n  2\\. Age≥18 years old, and≤70 years old ; 3. Pathologically diagnosed as solid tumors, including bone or soft tissue sarcoma, and staging for advanced or unresectable patients ; 4. Patients with first-line treatment failure ; 5. No previous tumor vaccine treatment ; no previous treatment with PD-1 antibody ; 6. According to the RECIST1.1 standard, there are measurable lesions and superficial lesions ; 7. The following three screening indicators should be met in the test screening period:\n\n  （1）The available tumor tissue samples ( paraffin sections and fresh surgical specimens ) were used for subsequent whole exome and transcriptome sequencing analysis and primary cell culture to obtain tumor neoantigen-related mutation sequence information and gene expression.\n\n( 2 ) Available peripheral blood samples; ( 3 ) Tumor new antigen prediction analysis and in vitro laboratory testing; 8. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 6 months ; 9. Patients were not allowed to use anti-tumor drugs and radiotherapy within 4 weeks before vaccination; 10. Patients with brain metastasis who were stable for at least one month after treatment can be included; 11. echocardiography showed left ventricular ejection fraction ≥ 50 %; 12. The results of laboratory tests should meet at least the following indicators :\n\n1. White blood cell count ≥ 3.0 × 109 \u002F L;\n2. absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ;\n3. absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L;\n4. platelet ( PLT ) ≥ 75 × 109 \u002F L;\n5. hemoglobin ≥ 90g \u002F dL ( no blood transfusion in the past 7 days ) ;\n6. Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n7. partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy;\n8. serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min;\n9. Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN;\n10. Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN;\n11. total bilirubin ( TBIL ) ≤ 1 × ULN 13. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment; 14. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.","18 Years","70 Years",{"count":174,"type":22},16,[25],"The primary objective of this trial is to evaluate the safety and tolerability of the tumor neoantigen vaccine (SarcVac) in combination with a PD-1 antibody, with or without tumor-specific lymphocytes, in patients with advanced bone and soft tissue sarcoma who have failed first-line treatment. The secondary objectives are to assess the preliminary efficacy of SarcVac combined with a PD-1 antibody, with or without tumor-specific lymphocytes, in these patients and to evaluate whether the vaccine's efficacy demonstrates dose dependency.",[178,30],"Soft Tissue Sarcoma (STS)","2026-06-12",{"date":181,"type":41},"2026-06-15",{"date":183,"type":41},"2024-09-03",{"date":185,"type":22},"2027-06-30",{"name":187,"class":78},"Sun Yat-sen University",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100617691","phase-2-eflornithine-dfmo-for-ewing-sarcoma-and-osteosarcoma-100617691","NCT07321912","Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma","Cohort 1:\n\nInclusion Criteria:\n\n1. Participants must be ≤50 years of age at enrollment.\n2. Histologically confirmed Ewing sarcoma that is refractory or in first or subsequent relapse. Histological confirmation either at initial diagnosis or disease progression.\n\n   * Relapsed: Participants that have achieved CR at any point and then relapsed following\u002Fduring standard of care therapy.\n   * Refractory: Participants that failed to achieve CR after standard of care therapy or having progressed during standard of care therapy.\n   * Note: Standard of care therapy for Ewing sarcoma includes multi-agent chemotherapy with local control consisting of either surgery and\u002For radiation therapy.\n3. Extent of disease is judged by treating team to be amenable to the delivery of definitive local control (either definitive radiation, surgery, or a combination of these) at the time of study enrollment (to be completed after protocol defined Cycle 2).\n4. Participants may enroll anytime during Cycle 1 or 2, prior to local control, as long as they received the same treatment during Cycle 1 and 2 as prescribed in this protocol.\n5. Relapsed or refractory disease, including at least one of the following:\n\n   * Tumor by CT or MRI\n   * FDG-PET that is positive for disease\n   * Bone Marrow biopsy\u002Faspirate that is positive for disease\n\n   Organ Function Requirements:\n6. Participants must have adequate renal function as defined as:\n\n   * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n   * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n   * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n7. Adequate liver function defined as:\n\n   1. Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n   2. SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n8. Adequate cardiac function defined as:\n\n   1. Shortening fraction of ≥27% or\n   2. Ejection fraction of ≥50%\n9. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n10. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Participants with current CNS disease.\n3. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n4. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n5. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n6. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 2:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be ≤50 years of age at enrollment.\n\n     Note:\n\n     • Infants and small children are eligible for this study, however, the treating physicians and family must be prepared to deliver adequate local control as required in this study (see BCC Surgical and Imaging Guidelines).\n\n     Diagnosis\n  2. Participants with histologic diagnosis (by institutional pathologist) of newly diagnosed Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) arising from bone or soft tissue and with metastatic disease involving lung, bone, bone marrow, or other metastatic site.\n\n     For the purpose of this study, metastatic disease is defined as one or more of the following:\n     * Lesions which are discontinuous from the primary tumor, are not regional lymph nodes, and do not share a bone or body cavity with the primary tumor. Skip lesions in the same bone as the primary tumor do not constitute metastatic disease. Skip lesions in an adjacent bone are considered bone metastases. If there is any doubt whether lesions are metastatic, a biopsy of those lesions should be performed.\n     * Contralateral pleural effusion and\u002For contralateral pleural nodules.\n     * Distant lymph node involvement.\n     * Participants with pulmonary nodules are considered to have metastatic disease if the participant has:\n\n       * Solitary nodule ≥0.5 cm or multiple nodules of ≥0.3 cm unless lesion is biopsied and negative for tumor;\n       * Participants with solitary nodule \\\u003C0.5 cm or multiple nodules \\\u003C0.3 cm are not considered to have lung metastasis unless biopsy documents tumor.\n     * Bone marrow metastatic disease is based on morphologic evidence of Ewing sarcoma based on H\\&E stains. In the absence of morphologic evidence of marrow involvement on H\\&E, participants with bone marrow involvement detected ONLY by flow cytometry, RT PCR, FISH, or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study.\n\n     For participants that have a positive FDG-PET scan at study enrollment, a bilateral bone marrow biopsy will be required at study entry. If a bone marrow is required, the suggested approach for participants with large pelvic tumors in which a posterior iliac crest bone marrow biopsy would track through the tumor is to instead undergo 2 marrow biopsies on the contralateral side (either 2 posterior biopsies or one posterior and one anterior biopsy).\n\n     • Bone metastasis: This study utilizes whole body FDG-PET scans to screen participants for bone metastases. Areas suspicious for bone metastasis based on FDG-PET scans require confirmatory anatomic imaging with either MRI or CT (whole body FDG-PET\u002FCT or FDG-PET\u002FMR scan acceptable). Whole body technetium bone scans may be performed at the discretion of the investigator and are not required. For participants without other sites of metastatic disease whose sole metastatic site to qualify for study entry is a single area suspicious for bone metastasis identified by FDG-PET, confirmatory biopsy or anatomic imaging evidence of an associated soft tissue mass at that site is required for study entry.\n\n     Prior Therapy\n  3. Participants must have completed 6 cycles of Induction therapy with VDC\u002FIE per US standard of care (including standard modifications). Participants will enroll after the 6th cycle prior to local control.\n\n     Organ Function Requirements\n  4. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  5. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age, and\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age (except for participants with liver metastasis who may enroll if ALT \\\u003C 5 times ULN for age).\n  6. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27% or\n     * Ejection fraction of ≥50%\n  7. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n  8. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n  9. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  10. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with regional node involvement as their only site of disease beyond the primary tumor.\n5. Participants whose primary tumors arise in the intra-dural soft tissue (e.g. brain and spinal cord).\n6. Participants with current CNS disease\n7. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n8. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in whom compliance is likely to be suboptimal, should be excluded.\n\nCohort 3:\n\nInclusion Criteria:\n\n* Age\n\n  1. Participants must be less than 30 years of age at enrollment.\n\n     Diagnosis\n  2. Participants must have histologic diagnosis of osteosarcoma at original diagnosis.\n  3. Participants must have had at least one episode of disease recurrence in the lungs without limitation on number of episodes of recurrence as long as they meet the following criteria:\n\n     * Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 4 weeks prior to study enrollment\\*\n     * Pathologic confirmation of metastases from at least one of the resected sites.\n     * No local recurrence or metastatic disease elsewhere. \\*For participants with bilateral pulmonary metastases, resection must be performed from both lungs and the study enrollment must be within 4 weeks from date of the last lung surgery. No evidence of pulmonary metastatic disease; participants may have no visible lung nodules greater than 3 mm, and not considered to be disease.\n\n     Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, participants will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Participants with positive microscopic margins will be eligible to enroll.\n\n     Performance Level\n  4. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60.\n\n     Timing from Prior Therapy\n  5. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.\n\n     * Myelosuppressive anti-cancer therapy: Must not have been received within 2 weeks of study entry (4 weeks if prior nitrosourea).\n     * Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.\n     * Radiation therapy (RT): ≥2 weeks for local palliative RT (small port); ≥6 weeks must have elapsed if prior craniospinal RT or if ≥50% radiation of pelvis; ≥6 weeks must have elapsed if other substantial BM radiation.\n     * Surgery: ≥2 weeks from last major surgery, including pulmonary metastasectomy, with the exclusion of a central line placement and core needle or small open biopsies.\n\n     Organ Function Requirements\n  6. Hematological:\n\n     * Platelet count ≥50,000\u002FμL without transfusion in last 7 days\n     * Hgb ≥8.5 without transfusion in last 7 days\n  7. Adequate renal function defined as:\n\n     * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n     * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n     * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n  8. Adequate liver function defined as:\n\n     * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age.\n     * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n  9. Adequate cardiac function defined as:\n\n     * Shortening fraction of ≥27%, or\n     * Ejection fraction of ≥50%.\n  10. Adequate pulmonary function defined as:\n\n      o No evidence of dyspnea at rest, no history of exercise intolerance, and a pulse oximetry \\>94%.\n  11. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n  12. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Participants with distant bone metastases at original diagnosis or any subsequent relapse (participants with only skip lesions will be eligible).\n5. Participants with concurrent local and pulmonary recurrence at the time of most recent episode of disease recurrence preceding enrollment.\n\n   Note: participants who had local recurrence previously that has been treated and then presented with an isolated pulmonary recurrence and met the surgical resection criteria stated above will be eligible (see IC #3 above).\n6. Participants with primary refractory disease with progression of the primary tumor on initial therapy.\n7. Participants with other sites of extra-pulmonary metastases at the time of any episode of disease recurrence preceding enrollment.\n8. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n9. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.\n\nCohort 4A\u002FB:\n\nInclusion Criteria:\n\nDiagnosis Both Cohorts\n\n1. Participants must have high grade osteosarcoma and received gross total resection prior to start of Cycle 3 MAP therapy. Participants with positive margins are eligible and may receive radiation therapy. This includes secondary malignancies.\n\n   o Note: craniofacial osteosarcoma is NOT permitted.\n2. The primary tumor was resectable after the initial 2 cycles of MAP chemotherapy.\n3. Participants must have had a non-contrast chest CT and primary tumor site imaging consisting of an MRI or CT for optimal visualization of primary tumor site prior to local control. Physical scans and scan reports must be available to submit to BCC.\n\n   Note: Two-view plain radiographs of the primary tumor site can be performed for participants who have a metallic prosthetic implant instead of CT or MRI if a significant metal artifact would occur by those imaging modalities;\n\n   Cohort A only\n4. Participant must have poor response to induction chemotherapy (those with 10% or more viable tumor remaining after surgery) and localized tumor.\n\n   Cohort B only\n5. Have an initial diagnosis of high-grade metastatic extremity or axial osteosarcoma resectable by the treating team.\n\n   o Note: Metastatic pulmonary disease is defined as 3 or more lesions \\>5 mm or 1 lesion \\>1 cm or biopsy proven pulmonary metastatic disease if not meeting these radiographic criteria;\n6. No definite progression of metastatic disease and no evidence of new metastatic disease.\n7. Following definitive primary surgery, complete removal of all metastases or complete removal planned and deemed feasible.\n\n   Non-Diagnostic Inclusion Criteria, Both Cohorts Age\n8. Participants must be ≥5 years and ≤40 years on date of diagnostic biopsy. Performance Level\n9. Participants must have a Lansky Play Scale or Karnofsky Performance Scale score of ≥ 60. Participants whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible.\n\n   Prior Therapy\n10. Participants must have completed standard induction therapy for initial diagnosis osteosarcoma (2 cycles \\[10weeks\\]) of MAP, Local control (surgery, assessment of histologic response), and a post-surgery 3rd cycle (5 weeks) of MAP. Participants will enroll after the 3rd cycle of MAP.\n\n    Organ Function Requirements\n11. Participants must have adequate renal function defined:\n\n    * For participants \\\u003C 17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Bedside Schwartz equation (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Bedside Schwartz equation is: \\[(0.413) X (Height in cm)\\] \u002F SCr\n    * For participants ≥17 years old: estimated Glomerular Filtration rate (eGFR) as calculated from the Cockcroft and Gault formula (in units of mL\u002Fmin\u002F1.73 m2) or via radioisotope GFR of ≥ 70 mL\u002Fmin\u002F1.73 m2. The Cockcroft and Gault formula is: \\[(140-age) x (Wt in kg) x (0.85 if female)\\] \u002F (72 x SCr)\n    * OR a 24 hour urine Creatinine clearance ≥ 70 mL\u002Fmin\u002F1.73 m2\n12. Adequate cardiac function defined as:\n\n    * Shortening fraction of ≥28%, or\n    * Ejection fraction of ≥50%\n13. Adequate liver function defined as:\n\n    * Total bilirubin ≤1.5 x upper limit of normal (ULN) for age\n    * SGPT (ALT \\\u003C3 x upper limit of normal (ULN) for age.\n14. Participants must have fully recovered from the hematological and bone marrow suppression effects of prior chemotherapy.\n15. Participants of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method. Participants who are lactating must agree to stop breast-feeding.\n16. Written informed consent in accordance with institutional and FDA guidelines must be obtained from all participants (or participants' legal representative).\n\nExclusion Criteria:\n\n1. BSA of \\\u003C0.25 m2\n2. Investigational Drugs: Participants who are currently receiving another investigational drug are excluded from participation.\n3. Anti-cancer Agents: Participants who are currently receiving other anticancer agents are not eligible.\n4. Infection: Participants who have an uncontrolled infection are not eligible until the infection is judged to be well controlled in the opinion of the investigator.\n5. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study, or in who compliance is likely to be suboptimal.","0 Years","50 Years",{"count":198,"type":22},406,[26],"Ewing sarcoma (EWS) and osteosarcoma primarily affect adolescents and young adults. Common treatments include chemotherapy, surgery and radiation, however, there have been few recent advancements in the standard of care. By incorporating eflornithine (DFMO) as an additional therapy and\u002For maintenance therapy we hope to safely observe improved event-free survival and overall survival. There are 5 cohorts covered under this master protocol.",[30,64,202],"Ewing Sarcoma Metastatic","2026-06-10",{"date":179,"type":41},{"date":206,"type":41},"2026-06-05",{"date":208,"type":22},"2036-06-01",{"name":101,"class":78},2,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":224,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100354889","phase-1-losartan--sunitinib-in-treatment-of-osteosarcoma-100354889","NCT03900793","Losartan + Sunitinib in Treatment of Osteosarcoma","A Phase I\u002FIb Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma","Inclusion Criteria:\n\n* 1\\. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form and provision of individual to provide assent for study).\n\n  2\\. Stated willingness to comply with all study procedures and be available for the duration of the study.\n\n  3\\. Male or female aged ≥ 10 years old. 4. Histologically confirmed osteosarcoma (at either original diagnosis or relapse) that has either recurred or progressed after at least one prior systemic therapy and for which no curative therapy exists.\n* Patients with surface or periosteal osteosarcoma are not eligible.\n* Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of active recurrence, are acceptable.\n\n  5\\. Disease status\n* Dose Escalation (Part A): Patients must have measurable or evaluable disease.\n* Cohort Expansion (Part B): Patients with measurable or evaluable disease and those with completely resected disease are eligible.\n\n  6\\. Performance status:\n* ECOG performance status (≥18 years old) ≤ 2 or Karnofsky performance score (\\\u003C18 years old)≥ 50.\n\n  7\\. Prior Therapy:\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met (e.g., blood count criteria) the patient is considered to have recovered adequately.\n\n  1. Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).\n  2. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent.\n\n  i. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n\nii. Corticosteroids: ≥ 14 days must have elapsed since last dose of corticosteroid.\n\niii. Hematopoietic growth factors: ≥ 14 days after the last dose of a long- acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor.\n\niv. Interleukins, Interferons and Cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors).\n\nv. Stem cell Infusions: Autologous stem cell infusion, including boost infusion: ≥ 42 days.\n\nvi. Cellular Therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) vii. XRT\u002FExternal Beam Irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial bone marrow radiation.\n\n* NOTE: Patients with history of cardiac irradiation with mean cardiac dose \\> 15 Gy are not eligible (see exclusion criteria).\n\n  8\\. Adequate bone marrow function, defined as:\n* Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n* Platelet count ≥ 75,000\u002Fmm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n* Hemoglobin ≥ 8 g\u002FdL (with or without transfusion) 9. Adequate renal function, defined as:\n* Creatinine clearance or radioisotope GFR \\> 70 mL\u002Fmin\u002F1.73 m2 OR a serum creatinine based on age\u002Fgender.\n\n  10\\. Adequate hepatic function, defined as:\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age\n* SGPT (ALT) ≤ 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n* Serum albumin ≥ 2.8 g\u002FdL 11. Patients with ≥ trace protein on urinalysis at screening will be allowed to enroll in the study at investigator discretion. A baseline urine protein creatinine ratio (UPC) should be obtained for patients with ≥ trace protein on urinalysis for consideration regarding Section 6.3.7 dose modification requirements.\n\n  12\\. Adequate cardiac function, defined as:\n* Current cardiac ejection fraction \\> 50% by biplane Simpson method on echocardiogram\n* QTc ≤ 480 ms 13. Patients with preexisting hyper- or hypothyroidism must be on a stable dose of medication.\n\n  14\\. Ability to take and retain oral medications. NOTE: Medication can be administered via nasogastric or gastrostomy tube.\n\nExclusion Criteria:\n\n1. Patients who underwent major surgery within 14 days prior to start of treatment are not eligible.\n\n   NOTE: Core biopsy or central line placement are considered minor and are allowed within any time limitations.\n2. Patients with uncontrolled coagulopathy or bleeding disorder, or any active bleeding (i.e., gastrointestinal or pulmonary) deemed to be clinically significant by investigator are not eligible.\n3. Patients with history of pulmonary embolism or significant thromboembolic event with the preceding 28 days. Patients with thromboembolic events \\> 28 days before enrollment who are stable on or completed an anticoagulation course are eligible.\n4. Patients with history of cardiac irradiation with mean cardiac dose \\> 15 Gy are not eligible.\n5. Patients with symptomatic cardiac disease (i.e. New York Heart Association or Modified Ross Heart Failure Classification for Children \\> class 2) are not eligible.\n6. Patients with any history of cardiac dysfunction including prior abnormal echocardiogram (ejection fraction \\\u003C 50%), severe or unstable angina, peripheral vascular disease, congenital prolonged QTc syndrome, clinically significant cardiac arrhythmias, stroke, or myocardial infarction are not eligible.\n7. Pregnancy\n\n   * Pregnant or breast-feeding women will not be entered on this study because there is not yet available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in females who are post-menarchal.\n   * Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 3 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. Patients who themselves or their partners have undergone female or male sterilization do not require 2 methods of contraception. Highly effective methods are defined as those with \\\u003C1% failure rate with perfect use and include: oral contraceptive pills (combined or progesterone only), intrauterine devices (IUD), hormonal implant or injection, contraceptive patch, and vaginal ring.\n8. Concomitant medications:\n\n   * Anti-hypertensives: Patients who cannot be controlled to goal blood pressure for gender\u002Fage are not eligible.\n   * Corticosteroids: Patients receiving systemic corticosteroids are not eligible. \\> 14 days must have elapsed since last systemic corticosteroid. Note: patients using topical or inhaled corticosteroids are eligible.\n   * Investigational Drugs: Patients currently receiving another investigational drug are not eligible.\n   * Anti-cancer agents: Patients currently receiving other anti-cancer agents are not eligible.\n   * Drug interactions: Patients who require treatment with medications that are strong inhibitors or inducers of CYP3A4 or inhibitors of CYP2A9 or have received these medications in the 7 days prior to enrollment, are not eligible. Patients who require treatment with enzyme inducing anticonvulsants are not eligible.\n   * Medications that prolong QTc: Patients who require treatment with medications known to prolong QTc are not eligible","10 Years",{"count":220,"type":22},41,[25],"This study is a Phase 1\u002F1b clinical trial that aims to determine the Maximally Tolerated Dose of Losartan and Sunitinib Combination Therapy. Patients will first be accrued to the Dose Escalation phase of the study, using a 3+3 design. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.",[30],[225,226,227,228,229,230,231],"Pediatrics","Adults","Phase 1","Losartan","Sunitinib","Maximum Tolerated Dose","Recommended Phase 2 Dose","2026-06-08",{"date":234,"type":41},"2026-06-11",{"date":236,"type":41},"2019-08-26",{"date":238,"type":22},"2029-08-01",{"name":240,"class":78},"University of Colorado, Denver",4,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":261,"locationsCount":79},"100602877","musculoskeletal-cancers-remote-monitoring-and-care-100602877","NCT07129226","Musculoskeletal Cancers Remote Monitoring and Care","Inclusion Criteria:\n\n* primary sarcoma or metastatic bone disease of the lower extremities or pelvis.\n* undergoing evaluation for (or have recently undergone) non-surgical or surgical intervention.\n* recent history of home ambulation.\n\nExclusion Criteria:\n\n* under 18 years of age at the time of study enrolment\n* inability to comprehend consent form and give informed consent\n* no access to a smartphone (iOS or Android) to interface with watch application\n* tattoos located on the skin of the wrist or forearm where the watch will be placed or other skin conditions preventing adequate sensor function\n* amputation or other disease of the arm or skin that prevents wear of a smart-watch device\n* inability to tolerate watch for at least 12 hours per day on at least 80% of days in a four-week period",{"count":249,"type":22},60,[59],"This study aims to evaluate how walking stability and the ability to perform daily activities change during cancer treatment, and whether a smartwatch can detect these changes. The goal is to develop proactive, personalized tools that automatically monitor treatment response and predict potential complications. To support future implementation, the study will assess the feasibility of wearing a smartwatch for at least 12 hours per day, using a mobile application, and completing weekly questionnaires among patients with primary osteosarcoma or metastatic bone disease.",[30,253],"Metastatic Bone Disease",[255],"prophylactic surgery","2026-06-03",{"date":258,"type":41},"2026-06-04",{"date":159,"type":41},{"date":73,"type":22},{"name":262,"class":78},"Case Comprehensive Cancer Center",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":17,"minAge":271,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":79},"100534153","phase-1-safety-and-feasibility-of-intraoperative-visualization-with-cytalux-in-children-100534153","NCT06235125","Safety and Feasibility of Intraoperative Visualization With Cytalux in Children","A Pilot Study of Near-Infrared Imaging Using the Novel Imaging Agent Cytalux for Adolescent Patients With Metastatic Osteosarcoma Undergoing Pulmonary Metastasectomy","Cytalux","Inclusion Criteria:\n\n1. Patients 6-17 years of age at the time of study enrollment\n2. Willingness of research participant or legal guardian\u002Frepresentative to give written informed consent\n3. Willingness of patients (subjects) age 12-17 to provide written adolescent assent\n4. Patient weight greater than or equal to 20 kg\n5. Histologically confirmed diagnosis of osteosarcoma, synovial sarcoma, hepatoblastoma, rhabdomyosarcoma, Ewing sarcoma, Wilms tumor or other non-rhabdomyosarcoma soft tissue sarcoma\n6. Imaging findings highly suspicious for pulmonary metastatic disease based on CT, PET-CT or other imaging and warranting pulmonary surgery based on the judgment of the treating team. At least one nodule ≥4mm measured by preoperative imaging.\n7. Female (assigned female at birth) participant is not pregnant and agrees to an acceptable form of contraception from the time of consent through 30 days after study intervention. Confirmed abstinence is an acceptable form of contraception.\n8. Female (assigned female at birth) participant must agree to not donate ova from time of consent until 30 days after study intervention\n9. Male (assigned male at birth) participant must agree to not donate sperm from time of consent until 30 days after study intervention.\n\nExclusion Criteria:\n\n1. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject\n2. History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will also be excluded.\n3. History of allergy to any of the components of CYTALUX™ (PAFOLACIANINE) INJECTION\n4. Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule\n5. Impaired renal function defined as eGFR\\\u003C 50 mL\u002Fmin\u002F1.73m2\n6. Impaired liver function defined as values \\> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \\>2x ULN for total bilirubin except in subjects with Gilbert's syndrome.\n7. Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration\n8. History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7).\n9. Participants will be excluded if their 12th or 18th birthday would occur during study participation\n10. Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.","6 Years","17 Years",{"count":274,"type":22},10,[25],"Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.",[30,278,279,280,225],"Pulmonary Metastasis","Fluorescence","Metastatic Sarcoma",{"date":206,"type":41},{"date":283,"type":41},"2024-04-08",{"date":285,"type":22},"2026-08-31",{"name":287,"class":78},"Ann & Robert H Lurie Children's Hospital of Chicago",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":79},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":22},[297],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[300,301,302,303,304,30,67,64,63,305,306,307,308,309,310],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":206,"type":41},{"date":314,"type":41},"2026-05-01",{"date":316,"type":22},"2028-05-01",{"name":318,"class":78},"University of California, Irvine",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":196,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":79},"100553966","phase-1-atezolizumab-in-combination-with-stereotactic-body-radiation-therapy-sbrt-and-surgery-for-relapsed-osteosarcoma-100553966","NCT06492954","Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma","Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma","AflacST2301","Inclusion Criteria:\n\n* Participants must have had histologic verification of osteosarcoma at the original diagnosis or relapse\n* Participants must be in first or greater relapse of osteosarcoma\n* Recurrence must be limited to the lung but can be unilateral or bilateral\n* All pulmonary nodules must be resectable as determined by the institutional surgeon. Resectable pulmonary nodules are defined as nodules that can be removed without performing a pneumonectomy (e.g., nodules immediately adjacent to the main stem bronchus or main pulmonary vessels). There is no maximum number of lesions provided the surgeon thinks a complete surgical remission can be achieved.\n* Participants must have at least 1 lesion that is ≥ 5 mm and meets the criteria to receive SBRT AND an additional nodule(s) that meets protocol definition for a metastatic nodule necessitating surgical resection: single nodule ≥ 5 mm, or ≥ 2 nodules ≥ 3 mm in size\n* Patients must have a Lansky (≤ 16 years) or Karnofsky (\\> 16 years) score of ≥ 60, or ECOG performance score of ≤ 2\n* All prior treatment-related toxicities must have resolved to ≤ Grade 1 OR be determined clinically stable by the treating investigator.\n\n  1. Myelosuppressive chemotherapy: ≥ 14 days after the last dose of myelosuppressive chemotherapy.\n  2. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., Pegfilgrastim) or 7 days for a short-acting growth factor.\n  3. Biologic (anti-neoplastic) agent: ≥ 7 days after the last dose of a biologic agent.\n  4. Cellular therapy: ≥ 21 days must have elapsed from the last dose of any type of cellular therapy (e.g., modified T cells, NK cells, dendritic cells, etc.) with resolution of any associated toxicities.\n  5. Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ≥ 21 days must have elapsed from the last dose of interleukins, interferon, or cytokines (other than hematopoietic growth factors).\n  6. Antibodies: 7 days or 3 half-lives (whichever is longer) but not longer than 30 days, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  7. Autologous Stem Cell Transplant or Rescue: ≥ 6 weeks must have elapsed since stem cell transplant or rescue.\n  8. Radiotherapy (XRT): ≥ 14 days after local palliative XRT (small port); ≥ 3 months must have elapsed if prior craniospinal XRT was received, if ≥ 50% of the pelvis was irradiated, or if TBI was received; ≥ 6 weeks must have elapsed if other substantial bone marrow radiation was given.\n  9. Investigational Agents Not Otherwise Specified: ≥ 28 days must have elapsed since the last dose of any investigational agent not specified above.\n  10. Thoracic Surgery or Procedure: ≥ 28 days must have elapsed since prior thoracotomy, thoracoscopy, or thoracentesis.\n* Adequate Bone Marrow Function Defined: Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3, Platelet count ≥ 50,000\u002Fmm3. Must be transfusion independent defined as not receiving platelet transfusions for at least 7 days before enrollment\n* Adequate Renal Function Defined As Creatinine clearance or radioisotope ≥ GFR 70ml\u002Fmin\u002F1.73 m2\n* Adequate Liver Function Defined As Total bilirubin ≤ 1.5 x the upper limit of normal (ULN) for age, ALT (SGPT) ≤ 3 x the ULN. For this study, the ULN for ALT (SGPT) is 45 U\u002FL.\n* Adequate Pancreatic Function Defined As Serum lipase ≤ 1.5 x ULN\n* Adequate Thyroid Function Defined As Normal free T4\n* Adequate Pulmonary Function Defined As No dyspnea at rest, Pulse oximetry \\> 92% on room air\n* Adequate Cardiac Function Defined As QTc ≤ 480 msec, Shortening fraction ≥ 27% by echocardiogram or ejection fraction ≥ 50% by gated radionuclide study or echocardiogram\n* Urine protein: Meets one of the following criteria: (1) urinary protein by urine dipstick is ≤ 100 mg\u002FdL or ≤ 2+; OR (2) Urine Protein Creatinine (UPC) ratio \\\u003C 3.5; OR (3) if 24-hour urine protein was measured, urinary protein ≤ 3500 mg.\n* Life expectancy of at least 4 months.\n* Negative urine or serum pregnancy test in women of childbearing potential.\n* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation. Patients should maintain adequate contraception for at least 5 months after the last dose of atezolizumab. Adequate contraception is defined as abstinence or use of contraceptives with a failure rate of \\\u003C 1% per year.\n* All participants and their parents or legal guardians must sign a written informed consent and assent (if applicable).\n\nExclusion Criteria:\n\n* Pregnancy or Breast-Feeding\n* Active metastatic disease outside of the lungs including bone, CNS, or any extrapulmonary involvement\n* \\> Grade 1 pleural effusion\n* Prior lung radiation\n* Active autoimmune disorder that has required systemic treatment in the past 12 months, or a documented history of severe autoimmune disorder, or a syndrome that requires systemic steroids or immunosuppressive agents. Participants with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders such as vitiligo, psoriasis, or alopecia not requiring systemic treatment may be permitted to enroll.\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months before initiation of study treatment, unstable arrhythmia, or unstable angina.\n* Prior treatment with an immune checkpoint inhibitor is allowed provided it was not permanently discontinued due to toxicity and was not given with radiation.\n* Active tuberculosis\n* Any medical condition or illness that would compromise the participants's ability to undergo surgery, cause unacceptable safety risk, or compromise compliance with the protocol.\n* Chronic use of immunosuppressive therapies.\n* Participants with an uncontrolled infection.\n* Subjects who have received prior allogeneic stem cell transplant or solid organ transplant are not eligible.\n* Participants who, in the opinion of the investigator, may not be able to comply with the protocol-required procedures.\n* Participants who are currently receiving any other investigational or anti-cancer agents.\n* Participants with a known history of HIV, hepatitis B, and\u002For hepatitis C (testing not required as part of screening).\n* Current or prior pneumonitis.\n* Live\u002Fattenuated vaccine administered within 30 days of enrollment",{"count":129,"type":22},[25],"This study aims to determine the safety and tolerability of combined Atezolizumab, stereotactic body radiation therapy (SBRT), and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma",[30,331],"Pulmonary Recurrence of Osteosarcoma",[30,333,334,331],"Stereotactic body radiation therapy","Atezolizumab","2026-05-30",{"date":311,"type":41},{"date":338,"type":22},"2026-07",{"date":340,"type":22},"2027-06",{"name":342,"class":78},"Emory University",{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":350,"maxAge":172,"enrollmentInfo":351,"targetDuration":4,"studyType":23,"phases":353,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":79},"100639048","phase-2-cryoablation-plus-camrelizumab-for-advanced-soft-tissue-sarcoma-100639048","NCT07602049","Cryoablation Plus Camrelizumab for Advanced Soft Tissue Sarcoma","A Prospective, Single-Center, Single-Arm Phase II Clinical Trial of Cryoablation Combined With Camrelizumab in the Treatment of Advanced or Unresectable Soft Tissue Sarcoma Refractory to Standard Therapy","Inclusion Criteria:\n\n1. Before any procedures related to the research program, including screening and evaluation stage, signed informed consent.\n2. Age≥14 years old, and≤70 years old ;\n3. Pathologically diagnosed as soft tissue sarcomas, and staging for advanced or unresectable patients ;\n4. Patients with standard treatment (such as chemotherapy) failure ;\n5. No previous treatment with PD-1 antibody ; or those who have previously received PD-1 antibody therapy and progressed at least half a year later;\n6. According to the RECIST1.1 standard, there are ≥3 measurable lesions; the distribution sites of multiple lesions are in ≤3 organs (which may include the abdominopelvic cavity, extremities, liver, lungs, pleura, etc.); the size of the target lesions is 1.0 - 5.0 cm.\n7. ECOG score 0-1 ( see Appendix ) and expected survival time greater than 3 months ;\n8. Patients with brain metastasis who were stable for at least one month after treatment and who do not require the use of glucocorticoids can be included.\n9. echocardiography showed left ventricular ejection fraction ≥ 50 %;\n10. The results of laboratory tests should meet at least the following indicators :\n\n（1）White blood cell count ≥ 3.0 × 109 \u002F L; （2）absolute neutrophil count ( ANC ) ≥ 1.5 × 109 \u002F L ( without GCSF support ) ; （3）absolute lymphocyte count ( ALC ) ≥ 1.0 × 109 \u002F L; （4）platelet ( PLT ) ≥ 75 × 109 \u002F L; （5）hemoglobin ≥ 10g \u002F dL ( no blood transfusion in the past 7 days ) ; （6）Prothrombin time or INR ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （7）partial thromboplastin time ( APTT ) ≤ 1.5x normal upper limit time, unless receiving anticoagulant therapy; （8）serum creatinine ≤ 1.5 × ULN ( upper limit of normal ) ; 24-hour creatinine clearance rate ≥ 60 mL \u002F min; （9）Aspartate Aminotransferase (AST\u002FSGOT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （10）Alanine Aminotransferase (ALT\u002FSGPT) ≤ 2 × ULN or 5×ULN (for patients with liver metastases).; （11）total bilirubin ( TBIL ) ≤ 1 × ULN 11. Females with fertility were negative in pregnancy test before treatment ; consent must be given to the use of contraception or the prohibition of same-sex or opposite-sex sexual activity during treatment.\n\n12\\. During the whole experiment, we can regularly go to the research institutions to carry out relevant testing, evaluation and management.\n\nExclusion Criteria:\n\n1. Concurrently having other malignant tumors within 5 years.;\n2. Patients who received major surgeries, conventional chemotherapy, large-area radiotherapy, biotherapy or interventional ablation therapy for anti-tumor treatment within 4 weeks before entering the trial;\n3. known for any component of this test treatment will produce allergic reactions ;\n4. No recovery from previous surgery or treatment-related adverse reactions to \\\u003C Level 2 CTCAE;\n5. Uncontrolled hypertension ( systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 90 mmHg ) or clinically significant cardiovascular and cerebrovascular diseases ( such as activity ), such as cerebrovascular accident ( within 6 months before the signing of informed consent ), myocardial infarction ( within 6 months before the signing of informed consent ), unstable angina, New York Heart Association ( Appendix ) grade II or above congestive heart failure, or severe arrhythmia can not be controlled with drugs or have a potential impact on research and treatment ; the electrocardiogram showed obvious abnormality or average QTc interval ≥ 450 milliseconds in three consecutive times.\n6. Combined with other serious organic diseases and mental disorders;\n7. Patients with systemic active infections requiring treatment, including active tuberculosis, known HIV-positive patients or clinically active hepatitis A, B, and C patients, in the case of chronic hepatitis B virus infection, the HBV-DNA level should be ≤ 10E3.\n8. Patients with autoimmune diseases : patients with a history of inflammatory bowel disease and a history of autoimmune diseases ( such as systemic lupus erythematosus, vasculitis, and invasive lung disease ) that were judged by the researchers to be unsuitable for this study need to be excluded. (Patients with vitiligo and those with Hashimoto's thyroiditis with normal thyroid function will not be excluded.)\n9. During the 4 weeks prior to therapy, if there has been use of chronic systemic corticosteroids, hydroxyurea, immunomodulatory drugs (such as interleukin-2, α or γ interferons, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.).\n10. History of organ transplantation, autologous \u002F allogeneic stem cell transplantation and renal replacement therapy;\n11. known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;\n12. Known alcohol and\u002For drug abuse;\n13. Pregnant or lactating women;\n14. With any researchers determine that may damage the test carried out in the coexistence of medical conditions or diseases of the test;\n15. No legal capacity \u002F limited capacity.","14 Years",{"count":352,"type":22},57,[26],"The main purpose of this trial is to investigate and evaluate the efficacy of cryoablation combined with camrelizumab treatment to patients with advanced or inoperable soft tissue sarcomas after standard treatment failure.",[178,30],"2026-05-20",{"date":358,"type":41},"2026-05-22",{"date":360,"type":41},"2024-11-20",{"date":362,"type":22},"2027-11-30",{"name":187,"class":78},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":23,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":79},"100431379","phase-1-b7-h3-specific-chimeric-antigen-receptor-autologous-t-cell-therapy-for-pediatric-patients-with-solid-tumors-3car-100431379","NCT04897321","B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)","Inclusion Criteria:\n\nProcurement and T-cell production eligibility\\*\n\n\\*a previously collected, autologous leukapheresis product can be used for T-cell production\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease; B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) using a previously obtained biopsy; a tumor is considered B7-H3 positive with an H-score ≥100\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* Known HIV positivity\n* Severe intercurrent bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Rapidly progressive disease (in the opinion of the study PIs)\n\nInclusion criteria\n\nTreatment eligibility\n\n* Age ≤21 years old\n* B7-H3+ solid tumor with measurable disease\n* Evidence of relapsed or refractory disease after standard first-line therapy\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Echocardiogram with a ventricular ejection fraction\n* \\>40%; or shortening fraction ≥25%\n* Adequate renal function defined as creatinine clearance or radioisotope GFR 50 ml\u002Fmin\u002F1.73m2 (GFR 40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as pulse oximetry ≥92% on room air or forced vital capacity (FVC) ≥50% of predicted value\n* Total Bilirubin ≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Hemoglobin≥ 7g\u002FdL (can be transfused)\n* Platelet count \\>50,000\u002FuL (can be transfused)\n* Absolute neutrophil count (ANC) ≥ 1000\u002FuL\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child bearing age:\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Not lactating with intent to breastfeed\n* If sexually active, agreement to use birth control until 3 months after T-cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n* Agreement to participate in long-term follow-up protocol for patients, who have received genetically modified cell products\n\nExclusion criteria\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe, uncontrolled intercurrent bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* Receiving systemic steroid therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to B7-H3-CAR T-cell infusion\n* Receiving systemic therapy in the 14 days prior to CAR T-cell infusion, which will interfere with the activity of the B7-H3-CAR product (in the opinion of the study PIs).\n* Rapidly progressing disease (in the opinion of the study PIs)","21 Years",{"count":372,"type":22},48,[25],"3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed\u002Frefractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors.\n\nPrimary objective\n\nTo determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent\u002Frefractory B7-H3+ solid tumors after lymphodepleting chemotherapy\n\nSecondary objective\n\nTo evaluate the antitumor activity of B7-H3-CAR T cells\n\nExploratory objectives\n\n* To evaluate the tumor environment after treatment with B7-H3-CAR T cells\n* To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells",[376,30,63,93,64,36,377,29,378,149,146,379,306,380,381,67],"Pediatric Solid Tumor","Adrenocortical Cancer","Germ Cell Cancer","Hepatoblastoma","Carcinoma","Malignant Peripheral Nerve Sheath Tumors","2026-05-18",{"date":384,"type":41},"2026-05-19",{"date":386,"type":41},"2022-07-06",{"date":388,"type":22},"2028-03-01",{"name":77,"class":78},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":399,"phases":4,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":417},"100193148","effects-of-dexrazoxane-hydrochloride-on-biomarkers-associated-with-cardiomyopathy-and-heart-failure-after-cancer-treatment-100193148","NCT01790152","Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment","Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy","Inclusion Criteria:\n\nStudy Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV\n\n* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS\n* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)\n* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia\u002Flymphoblastic lymphoma \\[P9404, high-risk DFCI 95-01\\] or Hodgkin lymphoma \\[P9425\u002FP9426\\])\n* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation\n* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \\[also includes fields directed towards the neck, upper abdomen, or spine\\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible\n* STRATUM I: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \\[COG?s\\] Statistics and Data Center \\[SDC\\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse\u002Fsubsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)\n* STRATUM II: Alive, but have experienced relapse of their original cancer and\u002For have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis\n* STRATUM II: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM III: OSTEOSARCOMA SURVIVORS\n* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and\u002For parents\u002Flegal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors\n* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:\n\n  * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible\n  * \\\u003C 31 years of age at time of initial osteosarcoma diagnosis\n  * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002\n  * No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \\>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \\>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis\n  * Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg\u002Fm\\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria\n  * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies\n  * No exposure to DRZ at any point in time\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3\n* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and\u002For radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year\n* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \\[DICOM\\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable\n* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)\n* Based on echocardiography, must have either left ventricular fractional shortening =\\\u003C 28.0% or ejection fraction =\\\u003C 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection\n* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \\[ACE\\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months\n* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":398,"type":22},420,"OBSERVATIONAL","This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.",[402,403,404,30,405,406,407],"Hodgkin Lymphoma in Remission","Leukemia in Remission","Lymphoblastic Lymphoma","Recurrent Leukemia","Recurrent Lymphoma","Recurrent Malignant Neoplasm","2026-05-14",{"date":382,"type":41},{"date":411,"type":41},"2014-03-05",{"date":413,"type":22},"2026-12-31",{"name":415,"class":416},"Children's Oncology Group","NETWORK",79,{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":446},"100477109","phase-1-start-safety-and-anti-tumor-activity-of-pepticrad-1-in-treatment-of-cancer-100477109","NCT05492682","START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer","A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3","Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female, ≥18 years of age.\n3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to\u002Fafter standard therapy or the patient has refused or does not tolerate standard therapy:\n\n   * Inoperable\u002Fmetastatic cutaneous malignant melanoma\n   * Relapsed or newly diagnosed locally advanced inoperable\u002Fmetastatic TNBC\n   * Inoperable advanced\u002Fmetastatic non-squamous NSCLC\n   * Inoperable and\u002For advanced Synovial or myxoid round cell sarcoma\n   * Inoperable and\u002For advanced osteosarcoma\n   * Inoperable and\u002For advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n   * Inoperable and\u002For advanced\u002Fmetastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n5. Tumor lesion which is deemed feasible for biopsy and injection\n6. ECOG\u002FWHO performance status 0 to 1.\n7. Acceptable liver and renal function, defined as:\n\n   * Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and\n   * Serum creatinine ≤1.5 x ULN\n8. Acceptable hematological function, defined as:\n\n   * Hemoglobin ≥9 g\u002FdL, and\n   * Neutrophils ≥1.5 x 109\u002FL, and\n   * Platelet count ≥100 x 109\u002FL Patients may be transfused to meet the hemoglobin entry criteria.\n9. Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal.\n10. Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period.\n\n    Urine pregnancy tests should have a sensitivity of at least 25 mIU\u002FmL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood.\n11. Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment\n\nExclusion Criteria:\n\n1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.\n2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \\>10 mg\u002Fday prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.\n3. Prior or concomitant radiotherapy within 4 weeks before Day 1.\n4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.\n5. Active bacterial, viral, or fungal infection that requires systemic therapy.\n6. Active autoimmune disease that has required systemic treatment in the past two years.\n7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.\n8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.\n9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.\n10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.\n\n    Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.\n11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:\n\n    * Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1\n    * Grade 2 or higher pneumonitis\n    * Grade 4 AST or ALT elevation\n    * Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.\n12. History of or planned tissue \u002F organ transplant.\n13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.\n14. Unwillingness or inability to comply with the study protocol for any reason.\n15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities.\n16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and\u002For involved directly in the study.\n17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.",{"count":426,"type":22},15,[25],"This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.",[430,431,432,144,433,434,30,435],"Melanoma (Skin)","Triple-Negative Breast Cancer","Non-Small Cell Lung Cancer","Myxoid Liposarcoma","Colorectal Cancer","Sarcoma","2026-05-11",{"date":438,"type":41},"2026-05-12",{"date":440,"type":41},"2023-02-02",{"date":442,"type":22},"2027-05-31",{"name":444,"class":445},"Valo Therapeutics Oy","INDUSTRY",7,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":453,"phases":4,"briefSummary":454,"conditions":455,"keywords":456,"overallStatus":460,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":463,"locationsCount":79},"100406347","expanded-access-use-of-l-mtp-pe-for-the-treatment-of-osteosarcoma-100406347","NCT04571229","Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma","Inclusion Criteria:\n\n* Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.\n* Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma\n* L-MTP-PE is deemed to be of potential benefit by the treating investigator\n* Willing and able to understand and sign informed consent and assent as appropriate\n* Life expectancy \\> 6 weeks\n* Adequate organ function as follows:\n* Adequate bone marrow function defined as:\n\n  * absolute neutrophil count (ANC) ≥ 750\u002Fmm\\^3\n  * platelet count ≥ 30,000\u002F mm\\^3\n  * hemoglobin ≥ 8 g\u002Fdl\n* Adequate renal function defined as:\n\n  * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL\u002Fmin\u002F1.73m\\^2 OR\n  * Serum creatinine ≤ 2x the upper limit of normal based on age\u002Fgender\n* Adequate liver function defined as:\n\n  * Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease\n  * AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases\n* Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant\n\nExclusion Criteria:\n\n* Use of chronic steroids of other immunosuppressive agents\n* Pregnant or breast feeding","EXPANDED_ACCESS","This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.",[30],[457,458,459],"L-MTP-PE","Expanded Access","20-324","AVAILABLE","2026-05-08",{"date":436,"type":41},{"name":464,"class":78},"Memorial Sloan Kettering Cancer Center",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":399,"phases":4,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":79},"100521060","an-organoid-based-functional-precision-medicine-trial-in-osteosarcoma-100521060","NCT06064682","An Organoid-based Functional Precision Medicine Trial in Osteosarcoma","An Organoid-based Functional Precision Medicine Trial in Osteosarcoma: PREMOST","PREMOST","Inclusion \u002F exclusion criteria - Group1:\n\n\\- Patients without diagnosis of osteosarcoma and whose imaging studies are suggestive of osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes\n\nInclusion \u002F exclusion criteria - Group 2:\n\n\\- Patients whose imaging studies are suggestive of metastatic osteosarcoma and who are planned to undergo biopsy or surgery for diagnostic purposes",{"count":474,"type":22},40,"The purpose of this study is to examine if we can predict sensitivity of osteosarcoma to different chemotherapy agents using tissue cultures in the laboratory. We know that different chemotherapy agents can be used in the treatment, but not every sarcoma responds to them equally. It is important to understand if testing of the tissue obtained during a routine biopsy or surgery may be useful in selecting appropriate treatments. In addition, additional testing of the tumor, including genetic testing, will help us to understand osteosarcoma better.",[30],[30],"2026-05-07",{"date":436,"type":41},{"date":481,"type":41},"2024-02-12",{"date":483,"type":22},"2028-01-01",{"name":485,"class":78},"Jonsson Comprehensive Cancer Center",{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":493,"maxAge":87,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":498,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":79},"100554571","phase-1-autologous-b7-h3-chimeric-antigen-receptor-t-cells-in-relapsedrefractory-solid-tumors-100554571","NCT06500819","Autologous B7-H3 Chimeric Antigen Receptor T Cells in Relapsed\u002FRefractory Solid Tumors","Phase I Clinical Trial of Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Children and Young Adults With Relapsed or Refractory Solid Tumor Expressing B7-H3 Target","Inclusion Criteria:\n\n1. Histologically confirmed malignant solid tumor (including neuroblastoma, soft tissue sarcoma, osteosarcoma, Ewing Sarcoma, and Wilms tumor) with evidence of incurable disease and tumor recurrence\u002Fprogression after all available curative standard therapies.\n\n   1. Subjects with neuroblastoma must have received or be intolerant to anti-GD2 antibody therapy.\n   2. Subjects with Wilm's tumor must have received or be intolerant to ifosfamide or cyclophosphamide plus etoposide therapy or alternative salvage regimen.\n   3. Subjects with embryonal rhabdomyosarcoma must have received or be intolerant to Adriamycin-based therapy.\n   4. Subjects with surgically resected pulmonary osteosarcoma in first recurrence must have received surgical resection of metastatic nodules.\n2. Subjects during dose escalation must have evaluable or measurable disease. Subjects during dose expansion must have measurable disease, except neuroblastoma which may have MIBG positive disease only.\n3. B7-H3 positive expression on malignant cells is NOT required but archival tissue must be available, or the subject must be willing to undergo tissue biopsy for expression analysis.\n4. Age: Must be ≥ 2 and ≤ 30 years of age.\n\n   \\* For the first three subjects treated with B7-H3CART, must be ≥ 12 and ≤ 30 years of age.\n5. Performance Status: Patients \\> 16 years of age must have Karnofsky ≥ 50%. Patients ≤ 16 years of age must have Lansky scale ≥ 50%; or ECOG performance status ≤ 2.\n6. Prior Therapy\n\n   1. No limit to the number of prior therapies.\n   2. Prior Therapy Wash-out: At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives. Radiation therapy must have been completed at least 3 weeks prior to enrollment, with the exception that there is no time restriction if the subject has measurable\u002Fevaluable disease outside the radiation port or the site of radiation has documented progression.\n7. Normal Organ and Marrow Function (supportive care is allowed per institutional standards, i.e. filgrastim, transfusion)\n\n   * ANC ≥ 750\u002FuL\\*\n   * Platelet count ≥ 75,000\u002FuL\\*\n   * Absolute lymphocyte count ≥ 150\u002FuL\\*\n   * Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n     * Creatinine within institutional norms for age(i.e. ≤ 2 mg\u002FdL in adults or according to table below in children \\\u003C18 years) OR creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL\u002Fmin\n\n   Age (Years) Maximum \\& Serum Creatinine (mg\u002FdL):\n\n   Age (Years): ≤5 \\& Maximum Serum Creatinine (mg\u002FdL): 0.8 Age (Years): 5 \\\u003C age ≤ 10 Maximum Serum Creatinine (mg\u002FdL): 1.0 Age (Years): \\>10-18 Maximum Serum Creatinine (mg\u002FdL): 1.2 Age (Years): \\> 18 Maximum Serum Creatinine (mg\u002FdL): 2.0\n   * Serum ALT\u002FAST ≤ 2.5x ULN (unless elevated ALT\u002FAST is associated with disease involvement of the liver, in which case this criterion will be waived and not disqualify a patient).\n   * Total bilirubin ≤ 1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n\n     * Cardiac ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an ECHO,\n     * No clinically significant ECG findings\n     * No clinically significant pleural effusion\n     * Baseline oxygen saturation \\> 92% on room air\n\n       * if cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia ≥ Grade 3 if it is due to disease, based on the results of bone marrow studies.\n8. Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).\n9. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or for as long as CART cells are detectable in peripheral blood.\n10. Must provide informed consent. For subjects \\\u003C18 years old, or adults with limited decision-making capacity, their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric subjects will be included in age appropriate discussion and assent will be obtained for those \\> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he\u002Fshe will be asked to reconsent as an adult.\n\nExclusion Criteria:\n\n1. Receiving any other current investigational agents.\n2. History of other malignancy, except non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast), unless disease free for at least 3 years.\n3. Presence of untreated brain metastases will be excluded. Subjects with previous CNS tumor involvement that has been treated and is stable for at least 3 months following completion of therapy are permitted. Patients who are clinically stable as evidenced by no requirements for corticosteroids, no evolving neurologic deficits, and no progression of residual brain abnormalities without specific therapy, are permitted.\n4. Presence of fungal, bacterial, viral, or other infection that is uncontrolled. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n5. Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti HCV positive) as the immunosuppression contained in this study will pose unacceptable risk. A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n7. Any medical condition that in the judgement of the sponsor investigator is likely to interfere with assessment of safety or efficacy of study treatment.\n8. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n9. Pregnant females are excluded from this study because the effects of autologous B7-H3CART on the developing human fetus are unknown and because the chemotherapy agents used in this trial (cyclophosphamide and fludarabine) are category D agents with the potential for teratogenic or abortifacient effects. Additionally, because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with cyclophosphamide\u002Ffludarabine, breastfeeding should be discontinued if the mother is treated with cyclophosphamide\u002Ffludarabine. These potential risks may also apply to other agents used in this study.\n10. Primary immunodeficiency or history of systemic autoimmune disease (e.g., Crohns, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n11. Patients who require systemic corticosteroid or other immunosuppressive therapy. (A one-week washout from systemic corticosteroid or other immunosuppressive therapy is permitted.) Use of physiologic doses of corticosteroids (up to 3 mg\u002Fm2\u002Fday prednisone equivalent) are permitted. Use of topical, ocular, intra-articular, intra-nasal, or inhaled corticosteroids are permitted.\n12. In the investigator's judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.","2 Years",{"count":220,"type":22},[25],"The purpose of this study is to test the manufacturing feasibility and safety of intravenous (IV) administration of B7-H3CART in children and young adult subjects with relapsed and\u002For refractory solid tumors expressing B7-H3 target using a standard 3+3 dose escalation design.",[93,435,30],[499,500],"Chimeric Antigen Receptor","Autologous T-Cells",{"date":478,"type":41},{"date":503,"type":41},"2024-07-11",{"date":505,"type":22},"2029-07",{"name":507,"class":78},"Stanford University",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":196,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100457328","phase-3-thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma-100457328","NCT05235165","Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","Inclusion Criteria:\n\n* Patients must be \\\u003C 50 years at the time of enrollment.\n* Patients must have =\\\u003C 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \\>= 3 mm and all of which must be =\\\u003C 3 cm size.\n\n  * Note: Patient must have eligibility confirmed by rapid central imaging review.\n* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.\n* Patients must have a histological diagnosis of osteosarcoma.\n* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.\n* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.\n* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n\nExclusion Criteria:\n\n* Patients with unresectable primary tumor.\n* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as \"central\" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).\n* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.\n* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.\n* Patients with evidence of extrapulmonary metastatic disease.\n* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.",{"count":516,"type":22},62,[518],"PHASE3","This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.",[521,522,30],"Metastatic Malignant Neoplasm in the Lung","Metastatic Osteosarcoma",{"date":524,"type":41},"2026-05-05",{"date":526,"type":41},"2022-04-01",{"date":528,"type":22},"2031-03-31",{"name":415,"class":416},232,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":538,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":23,"phases":540,"briefSummary":541,"conditions":542,"keywords":543,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":79},"100596969","phase-1-safety-and-efficacy-of-dit309-in-advanced-bone-and-soft-tissue-sarcomas-100596969","NCT07052383","Safety and Efficacy of DIT309 in Advanced Bone and Soft Tissue Sarcomas","A Single-Arm, Open-Label Clinical Study to Evaluate the Safety and Efficacy of DIT309 Cell Injection in Subjects With Advanced Bone and Soft Tissue Sarcomas","Inclusion Criteria:\n\n1. Voluntarily agrees to participate in the clinical trial; is fully informed about the study and has signed the informed consent form (ICF); is willing and able to comply with all study procedures.\n2. Male or female patients aged ≥8 weeks.\n3. Histologically confirmed diagnosis of advanced bone and soft tissue sarcoma, who have failed or are intolerant to prior standard therapies.\n4. At least one measurable lesion as defined by RECIST version 1.1.\n5. Tumor tissue demonstrates positive expression for the target antigen according to the protocol-defined criteria.\n6. ECOG performance status of 0-1 within 24 hours prior to leukapheresis and prior to lymphodepletion.\n7. Life expectancy of more than 6 months.\n8. Adequate venous access for leukapheresis, with no contraindications for the procedure.\n9. Laboratory parameters must meet the following criteria:\n\n   1. Hematologic function: WBC ≥ 3.0 × 10⁹\u002FL; Hemoglobin ≥ 8.0 g\u002FdL; ANC ≥ 1.5 × 10⁹\u002FL; Platelets ≥ 75.0 × 10⁹\u002FL\n   2. Renal function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n   3. Hepatic function: ALT and AST ≤ 2.5 × ULN (≤ 5.0 × ULN for subjects with liver metastasis)\n   4. Total bilirubin ≤ 2.0 × ULN (excluding patients with Gilbert's syndrome, defined as persistent or recurrent unconjugated hyperbilirubinemia without evidence of hemolysis or hepatic pathology)\n   5. Coagulation: Without anticoagulation therapy, PT, APTT, or INR ≤ 1.5 × ULN\n   6. Negative pregnancy test for female subjects of childbearing potential\n10. Subjects of childbearing potential must agree to use effective contraception from the date of signing the informed consent through 6 months after the last infusion.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women\n2. Viral infections:\n\n   1. Positive serology for HIV antibodies or syphilis\n   2. Positive HBsAg or HBcAb with HBV DNA above the lower limit of detection in peripheral blood\n   3. Positive HCV antibody with detectable HCV RNA in peripheral blood\n3. Medical history and comorbidities:\n\n   1. Known hypersensitivity to DIT309 cells or any component of the investigational products (including fludarabine, cyclophosphamide, or trastuzumab), or history of severe allergic reactions\n   2. Known active autoimmune diseases (e.g., Crohn's disease, systemic lupus erythematosus); subjects with vitiligo or childhood asthma in complete remission and not requiring treatment in adulthood may be eligible; subjects requiring medical intervention such as bronchodilators for asthma are not eligible\n   3. Currently receiving systemic immunosuppressive therapy or anticipated need for long-term immunosuppression during the study (topical, inhaled, or intranasal corticosteroids used intermittently are allowed)\n   4. Prior exposure to any gene-modified T cell therapy (e.g., CAR-T or TCR-T) or any form of gene therapy\\*\n   5. History of uncontrolled neurological or psychiatric disorders that may increase the risk of participation or interfere with study results in the investigator's opinion, including but not limited to epilepsy, dementia, or major depression\n   6. Untreated or symptomatic CNS or leptomeningeal metastases\n   7. Unresolved toxicities from prior treatment that have not recovered to Grade ≤1 per CTCAE v5.0 (except for toxicities deemed not to pose safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or hypothyroidism managed with replacement therapy)\n   8. History of other primary solid malignancies\n   9. Major surgery or significant trauma within 1 month prior to leukapheresis\n   10. Any serious or uncontrolled comorbidity that, in the investigator's opinion, may increase risks associated with study participation or investigational drug administration, including but not limited to: cardiovascular or cerebrovascular disease, renal insufficiency, pulmonary embolism, coagulation disorders requiring long-term anticoagulation, active or uncontrolled infections requiring systemic treatment.","8 Years",{"count":426,"type":22},[25],"This is a open-Label, dose-escalation study to evaluate the safety, tolerability and antitumor activity of DIT309 in subjects with advanced bone and soft tissue sarcomas.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.",[30,67],[544],"Advanced","2026-04-29",{"date":524,"type":41},{"date":548,"type":41},"2025-11-06",{"date":550,"type":22},"2027-10-10",{"name":552,"class":445},"Tcelltech Inc.",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":560,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":399,"phases":4,"briefSummary":563,"conditions":564,"keywords":570,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":580},"100319721","assessment-of-healing-and-function-after-reconstruction-surgery-for-bone-sarcomas-100319721","NCT03442465","Assessment of Healing and Function After Reconstruction Surgery for Bone Sarcomas","Assessment of Healing and Function After Surgical Reconstruction for Neoplasms Involving Bone","Inclusion Criteria:\n\n* All patients undergoing reconstructive surgery for neoplasms involving bone on the orthopaedic surgery service at MSK\n* Current or prior history of primary neoplasms involving osseous structures, including all subtypes\n* Confirmation of diagnosis that has been performed by the MSK's Department of Pathology via direct review of tissue\u002Fslides\n* Patients must read and understand English\n* Age \\>\u002F=4\n* Patients must read and understand English\n\nExclusion Criteria:\n\n* Patients that weight \\\u003C17 kilograms","4 Years",{"count":562,"type":22},300,"The purpose of this study is to look at the amount of function that returns in participants that have reconstruction with bone graft or artificial device and in participants who have tumor surgery plus regenerative osseous surgery.\n\nThe study will look at the level of function for a period of 3 years after the surgery. Another purpose of this study is to look at how well the bone heals in participants undergoing regenerative surgery",[565,30,566,567,568,569],"Bone Sarcoma","Chondrosarcoma","Ewing's Sarcoma","Osseous Sarcoma","Bone Neoplasm",[571,464],"18-014","2026-04-16",{"date":574,"type":41},"2026-04-17",{"date":576,"type":41},"2018-02-14",{"date":578,"type":22},"2027-02-14",{"name":464,"class":78},5,{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":12,"sex":17,"minAge":171,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":590,"briefSummary":591,"conditions":592,"keywords":629,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":653,"completionDateStruct":655,"leadSponsor":657,"locationsCount":659},"100565188","phase-2-agnostic-therapy-in-rare-solid-tumors-100565188","NCT06638931","Agnostic Therapy in Rare Solid Tumors","Phase II Basket Study to Evaluate the Tissue-agnostic Efficacy of Anti-Programmed Cell Death Protein 1 (Anti-PD1) Monoclonal Antibody in Patients With Advanced Rare Tumors","ANTARES","Inclusion Criteria\n\n1. Age 18 years or older.\n2. Patients with immunohistochemistry for PD-L1 with a combined positive score (CPS) of 10 or higher.\n3. Patients with progression or intolerance to already approved and accessible treatments for the specific neoplasm and population.\n4. Documented disease progression radiologically after the last routine treatment.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Measurable lesion per RECIST v1.1. Lesions previously treated with radiotherapy can only be used as target lesions if they are confirmed to be progressing by imaging before enrollment.\n7. Male participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. No fertile partner;\n   3. Has a fertile partner who agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n\n      and\n   4. Agrees to abstain from sperm donation throughout the study period and for at least 6 months after the last dose of Nivolumab.\n8. Female participants must meet at least one of the following conditions:\n\n   1. Considered infertile;\n   2. Agrees to follow contraceptive guidance throughout the study period and for at least 6 months after the last dose of Nivolumab;\n9. Estimated life expectancy greater than 12 weeks, as determined by the investigator or delegated sub-investigator.\n10. Preserved organ functions defined by:\n\n    * Absolute neutrophil count ≥ 1,000;\n    * Hemoglobin ≥ 8.0 g\u002FdL (patients may receive transfusions to reach this level);\n    * Platelet count ≥ 100,000;\n    * Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN), or ≤ 3.0 × ULN for patients with Gilbert's syndrome;\n    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases);\n    * Creatinine clearance \\> 30 mL\u002Fmin (estimated by Cockcroft-Gault).\n11. Diagnosis of rare cancer (List I) confirmed by histopathological examination, with the possibility of including other types of rare tumors (incidence of less than 6 in every 100,000) after careful evaluation and approval by the study board.\n\n    * List I:\n\n      * Urachal adenocarcinoma\n      * Parathyroid carcinoma\n      * Nasopharyngeal epithelial tumors\n      * Fibrolamellar carcinoma of any primary site\n      * Angiosarcoma of any primary site\n      * Secretory breast carcinoma\n      * Anal cancer\n      * Metaplastic breast carcinoma\n      * Chromophobe renal carcinoma, Microphthalmia-associated Transcription Factor (MiT) family translocation renal carcinoma; renal carcinoma with Fumarate Hydratase (FH) or Succinate Dehydrogenase (SDH) deficiency\n      * Carcinosarcoma of any primary site\n      * Small intestine cancer\n      * Cholangiocarcinoma\n      * Sertoli-Leydig cell tumors\n      * Cervical cancer of non-epidermoid histology\n      * Tracheal epithelial tumors\n      * Non-cystadenoma salivary gland tumors\n      * Mesothelioma of any site\n      * Neuroblastoma\n      * Adrenal cancer\n      * Penile cancer\n      * Apocrine carcinoma\n      * Fibrosarcoma of any primary site\n      * Cancer of unknown primary site\n      * Hemangioblastoma of any primary site\n      * Thyroid cancer\n      * Hepatoblastoma\n      * Fallopian tube cancer\n      * Leiomyosarcoma of any primary site\n      * Vaginal cancer\n      * Neurofibrosarcoma of any primary site\n      * Gallbladder cancer\n      * Osteosarcoma of any primary site\n      * Bile duct cancer\n      * Clear cell endometrial carcinoma\n      * Yolk sac tumor of any primary site\n      * Non-epidermoid bladder cancer\n      * Vulvar cancer\n      * Kaposi's sarcoma\n      * Epithelial ovarian cancer\n      * Soft tissue sarcoma\n      * Urethral cancer\n      * Granulosa cell tumor of any primary site\n      * Cystadenoma carcinoma\n      * Primitive neuroectodermal tumor of any primary site\n      * Pure or mixed neuroendocrine tumors with neuroendocrine component\n      * Trophoblastic tumor\n\nExclusion Criteria\n\n1. Previous treatment lines with immunotherapy (immune checkpoint inhibitors).\n2. Pregnant or breastfeeding individuals.\n3. Limiting comorbidity, in the opinion of the investigator.\n4. Active infection.\n5. Major surgery within the last 4 weeks.\n6. Functional class II or greater heart failure.\n7. Myocardial infarction or stroke within the last 6 months.\n8. History of pulmonary fibrosis or pneumonitis.\n9. Autoimmune diseases, except for patients with vitiligo and\u002For controlled thyroid\u002Fhypothyroidism without the use of immunosuppressors.\n10. Second invasive primary tumor diagnosed in the last 3 years and\u002For with active disease, except for localized skin tumors (non-melanoma) that have been treated with curative intent.\n11. Patients with prolonged QT interval.\n12. Uncontrolled Central Nervous System (CNS) metastases. Patients who have previously received local treatment, such as radiotherapy, will be eligible if clinical and radiological stability is demonstrated in the 2 weeks prior to the start of treatment. Patients must not be using corticosteroids for managing CNS disease.\n13. Presence of meningeal carcinomatosis.\n14. Worsening renal and liver function in the 14 days prior to enrollment.\n15. History of solid organ transplantation with or without immunosuppression.\n16. Patients with untreated acquired immunodeficiency. Immunocompromised patients may be included as long as they do not have active opportunistic disease and\u002For active infection, after thorough clinical evaluation by the investigator or sub-investigator. HIV-positive patients must have documented undetectable viral load prior to inclusion.\n17. Chronic use of corticosteroids at doses greater than 10 mg\u002Fday of prednisone or equivalent. Patients with adrenal insufficiency of non-autoimmune etiology (e.g., previous bilateral adrenalectomy) may be included if they are clinically compensated with 10 mg\u002Fday of prednisone or equivalent or less.",{"count":49,"type":22},[26],"The ANTARES study is a phase II basket trial designed to evaluate the tissue-agnostic efficacy of the monoclonal anti-PD1 antibody, nivolumab, in patients with advanced or metastatic rare tumors.\n\nThe study aims to treat rare malignancies with PD-L1 expression (CPS ≥ 10), regardless of the tumor's tissue type or location. Patients who have not responded to standard treatments will be included, and treatment will last for up to 12 months. The study will assess objective response, progression-free survival, and biomarkers such as PD-L1, ctDNA, and microvesicles, in a multicenter collaborative effort to provide innovative therapeutic options for this underrepresented population",[593,594,595,596,597,598,599,600,601,602,603,604,605,606,93,607,608,609,610,611,612,613,379,614,305,615,616,617,30,618,619,620,621,622,623,67,624,625,626,627,628],"Urachal Cancer","Parathyroid Carcinoma","Fibrolamellar Carcinoma","Angiosarcoma","Secretory Carcinoma of Breast","Anal Neoplasms","Metaplastic Breast Carcinoma","Translocation Renal Cell Carcinoma","Carcinosarcoma","Small Intestine Neoplasms","Cholangiocarcinoma","Sertoli-Leydig Cell Tumor","Adenoid Cystic Carcinoma","Mesothelioma","Adrenal Gland Neoplasms","Penile Neoplasms","Apocrine Carcinoma","Fibrosarcoma","Cancer of Unknown Primary","Hemangioblastoma","Thyroid Neoplasms","Fallopian Tube Neoplasms","Vaginal Neoplasms","Neurofibrosarcoma","Gallbladder Neoplasms","Biliary Tract Neoplasms","Clear Cell Endometrial Cancer","Yolk Sac Tumor","Vulvar Neoplasms","Kaposi Sarcoma","Ovarian Epithelial Cancer","Urethral Neoplasms","Granulosa Cell Tumor","Primitive Neuroectodermal Tumor","Neuroendocrine Tumors","Trophoblastic Tumor",[630,594,631,595,596,632,633,599,634,601,635,603,636,637,638,639,606,93,640,641,609,610,611,612,642,379,643,305,644,616,645,30,646,619,620,647,648,622,623,67,649,625,605,626,627,628],"Urachal Adenocarcinoma","Nasopharyngeal Epithelial Tumors","Secretory Breast Carcinoma","Anal Cancer","Chromophobe Renal Carcinoma","Small Intestine Cancer","Sertoli-Leydig Cell Tumors","Non-Squamous Cervical Neoplasm","Tracheal Epithelial Tumors","Non-Adenoid Cystic Salivary Tumors","Adrenal Neoplasm","Penile Cancer","Thyroid Cancer","Fallopian Tube Cancer","Vaginal Cancer","Gallbladder Cancer","Biliary Tract Cancer","Non-Squamous Bladder Cancer","Vulvar Cancer","Urethral Cancer","2026-04-10",{"date":652,"type":41},"2026-04-15",{"date":654,"type":41},"2024-07-16",{"date":656,"type":22},"2028-05",{"name":658,"class":78},"Instituto do Cancer do Estado de São Paulo",8,{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":664,"acronym":4,"eligibilityCriteria":665,"healthyVolunteers":12,"sex":17,"minAge":666,"maxAge":667,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":677,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":79},"100632643","mynavigate-a-guide-to-after-treatment-effects-for-adolescents-and-young-adults-100632643","NCT07516353","my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults","Inclusion Criteria:\n\n* Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.\n* Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.\n* Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia\u002FLymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.\n* Patients whose treatment includes alkylators, anthracyclines, and\u002For radiation.\n\nInclusion of Children:\n\n• This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be \\\u003C18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and\u002For those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.\n\nExclusion Criteria:\n\n* Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.\n* Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.\n* Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.\n* We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.","15 Years","24 Years",{"count":669,"type":22},143,[59],"This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).",[435,30,64,63,673,674,17,675,676],"Acute Myeloid Leukemia","Aml","Medulloblastoma","Acute Lymphoblastic Leukemia ,Lymphomas",[678,679,680,681,682,435,30,64,63,673,674,17,675],"Cancer Survivorship","Adolescent and Young Adult Cancer","Late Effects of Cancer Treatment","Hodgkin and mature B-cell Lymphomas","Acute Lymphoblastic Leukemia\u002FLymphoma","2026-03-31",{"date":685,"type":41},"2026-04-08",{"date":687,"type":22},"2026-08-20",{"date":689,"type":22},"2030-12-31",{"name":691,"class":78},"Dana-Farber Cancer Institute",{"id":693,"slug":694,"hasResults":12,"nctId":695,"briefTitle":696,"officialTitle":697,"acronym":4,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":17,"minAge":699,"maxAge":4,"enrollmentInfo":700,"targetDuration":4,"studyType":23,"phases":702,"briefSummary":703,"conditions":704,"keywords":705,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":715,"lastUpdatePostDateStruct":716,"startDateStruct":718,"completionDateStruct":720,"leadSponsor":722,"locationsCount":210},"100341092","phase-1-study-of-car-t-cells-targeting-the-gd2-with-il-15icaspase9-for-relapsedrefractory-neuroblastoma-or-relapsedrefractory-osteosarcoma-100341092","NCT03721068","Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed\u002FRefractory Neuroblastoma or Relapsed\u002FRefractory Osteosarcoma","A Phase I Study of Autologous Activated T-Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch Administered To Patients With Relapsed\u002FRefractory Neuroblastoma or Relapsed\u002FRefractory Osteosarcoma","All clinical and laboratory data required for determining eligibility must be available in the subject's medical\u002Fresearch record which will serve as the source document.\n\nBecause of the nature of iC9.GD2.CAR.IL-15 T cell product preparation, subjects will be assessed for initial study enrollment eligibility (prior to cell procurement) and then will have to meet criteria prior to starting lymphodepletion and prior to T cell infusion.\n\nInclusion Criteria for the Study:\n\n1. Written HIPAA authorization signed by legal guardian.\n2. Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for \\\u003C16 years of age).\n3. Life expectancy ≥12 weeks.\n4. Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. Bone marrow samples are acceptable as confirmation of neuroblastoma, confirmation of osteosarcoma at diagnosis\n5. High-risk neuroblastoma with persistent\u002Frefractory or relapsed disease, defined as:\n\n   1. First or greater relapse of neuroblastoma following completion of aggressive multi-drug frontline therapy.\n   2. First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy. Persistent\u002Frefractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (such as A3973 or ANBL0532).\n   3. Patients must be diagnosed with high risk neuroblastoma at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when \\>18 months of age as defined in the protocol or relapsed or refractory osteosarcoma that is not responsive to standard treatment.\n6. Measurable or evaluable disease per Revised INRC for subjects with neuroblastoma or measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 criteria for subjects with osteosarcoma.\n7. Adequate central nervous system function as defined by:\n\n   1. No known Central Nervous System ( CNS) disease\n   2. No seizure disorder requiring antiepileptic drug therapy\n\nExclusion Criteria for the Study Subjects meeting any of the following exclusion criteria will not be able to participate in this study (procurement, lymphodepletion, and cell infusion).\n\n1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n2. Has a known additional malignancy that is active and\u002For progressive requiring treatment.\n3. History of hypersensitivity reactions to murine protein-containing products.\n4. History of hypersensitivity to cyclophosphamide or fludarabine.","18 Months",{"count":701,"type":22},18,[25],"The body has different ways of fighting infections and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are molecules that fight infections and protect your body from diseases caused by bacteria and toxic substances. Antibodies work by sticking to those bacteria or substances, which stops them from growing and causing bad effects. T cells are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been enough to cure most patients.\n\nThis multicenter study is designed to combine both T cells and antibodies in order to create a more effective treatment. The treatment that is being researched is called autologous T lymphocyte chimeric antigen receptor cells (CAR) cells targeted against the disialoganglioside (GD2) antigen that express Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9), also known as iC9.GD2.CAR.IL-15 T cells.",[93,30],[706,707,708,709,710,711,712,713,714],"Autologous Chimeric Antigen Receptor (CAR) T Cells","Interleukin (IL)-15","Disialoganglioside (GD2)","Caspase 9","Pediatric","Rimiducid","AP1903","modified T cells","CAR T","2026-03-24",{"date":717,"type":41},"2026-03-27",{"date":719,"type":41},"2019-02-19",{"date":721,"type":22},"2044-06-19",{"name":723,"class":78},"UNC Lineberger Comprehensive Cancer Center"]