[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sarcoma-ewing\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sarcoma-ewing":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100570611","phase-1-phase-12-trial-to-evaluate-the-safety-and-efficacy-of-peel-224-in-combination-with-vincristine-and-temozolomide-in-adolescents-and-young-adults-with-relapsed-or-refractory-sarcomas-100570611",false,"NCT06709495","Phase 1\u002F2 Trial to Evaluate the Safety and Efficacy of PEEL-224 in Combination With Vincristine and Temozolomide in Adolescents and Young Adults With Relapsed or Refractory Sarcomas","Inclusion Criteria:\n\n-Patients in all cohorts must have relapsed or refractory disease after standard therapy.\n\nInclusion Criteria Phase 1 (only) diagnosis requirements:\n\n-Patients must have:\n\n* Evaluable or measurable disease; and\n* Histologic diagnosis of sarcoma\n\nInclusion Criteria Phase 2 (only) diagnosis requirements\n\n* EWS cohort: Patients must have:\n\n  * RECIST measurable disease at study entry;\n  * Histologic diagnosis consistent with Ewing sarcoma; and\n  * Molecular evidence of a FET-ETS family translocation including but not limited to any of the following:\n\n    * EWSR1::FLI1, EWSR1::ERG, EWSR1::ETV1, EWSR1::ETV4, EWSR1::FEV, FUS::FLI1, FUS::ERG\n* DSRCT cohort: Patients must have:\n\n  * RECIST measurable disease at study entry;\n  * Histologic diagnosis consistent with DSRCT; and\n  * Molecular evidence of an EWSR1::WT1 fusion\n* Other sarcoma cohort: Patients must have:\n\n  * RECIST evaluable or measurable disease; and\n  * Histologic diagnosis of sarcoma. Patients with EWS or DSRCT with evaluable but not measurable disease may participate in this cohort.\n  * Slots in this cohort will include three dedicated slots for patients with rhabdomyosarcoma, three dedicated slots for patients with osteosarcoma and three dedicated slots for patients with other translocation-associated round cell sarcomas.\n* Age: ≥ 12 years and ≤ 49 years.\n* Weight: Patients must be ≥ 40 kg.\n* Performance Status: Karnofsky ≥ 50% for patients \\>16 year of age and Lansky ≥ 50% for patients ≤ 16 years of age. (see Appendix A for definitions of Lansky and Karnofsky Performance Status).\n* Participants must meet the following organ and marrow function as defined below: Adequate Bone Marrow Function:\n\n  * Hematologic Requirements for Subjects without Bone Marrow Involvement by\n\nDisease:\n\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FuL\n* Platelet count ≥100,000\u002FuL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n\n  --Hematologic Requirements for Subjects with Bone Marrow Involvement by Disease:\n* ANC ≥750 \u002FuL\n* Platelets ≥50,000 \u002FuL (may receive platelet transfusions) Not known to be refractory to red cell and\u002For platelet transfusions.\n\n  --Adequate Renal Function: Creatinine clearance or radioisotope GFR ≥70ml\u002Fmin\u002F1.73 m2 or A serum creatinine based on age\u002Fsex as follows:\n* Age: 12 to \\\u003C 13 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.2, Female 1.2\n* Age 13 to \\\u003C 16 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.5, Female 1.4\n\n  ---≥ 16 years, Maximum Serum Creatinine (mg\u002FdL): Male 1.7, Female 1.4\n\n  --Adequate Liver Function:\n* Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age\n* SGPT (ALT) ≤110 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n\n  * Adequate Cardiac Function: QTc \\\u003C 480 msec\n\n    -Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy except organ function as noted above. Patients must meet the following minimum washout periods prior to enrollment:\n  * Myelosuppressive chemotherapy: At least 14 days after the last dose of myelosuppressive chemotherapy\n  * Radiotherapy:\n* At least 14 days after local XRT (small port, including cranial radiation);\n* At least 90 days must have elapsed after prior TBI, craniospinal XRT or if \\>50% radiation of pelvis;\n* At least 42 days must have elapsed if other substantial BM radiation.\n\n  * Small molecule biologic therapy: At least 7 days following the last dose of a biologic agent.\n  * Monoclonal antibody: At least 21 days must have elapsed after the last dose of antibody.\n  * Myeloid and platelet growth factors: At least 14 days following the last dose of long-acting myeloid growth factor (e.g. Neulasta) or 7 days following short-acting myeloid or platelet growth factor.\n  * Autologous hematopoietic stem cell transplant and stem cell boost: Patients must be at least 60 days from day 0 of an autologous stem cell transplant or stem cell boost.\n  * Cellular Therapies (e.g., CART, NK-cell based therapy): The patient must be and at least 42 days from cellular therapy administration.\n  * Major Surgery: At least 2 weeks from prior major surgical procedure. Note: Biopsy, CNS shunt placement\u002Frevision, and central line placement\u002Fremoval are not considered major.\n  * Irinotecan, liposomal irinotecan, and\u002For temozolomide: Patients may have received prior irinotecan, liposomal irinotecan, and\u002For temozolomide. NOTE: Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.\n\n    -For patients with metastatic disease to the CNS enrolling to the phase 1 portion of the trial or the \"other sarcoma\" cohort, any baseline neurologic deficits (including seizure) must be stable for at least one week prior to study enrollment. Patients with CNS metastatic disease receiving corticosteroids must be on a stable or decreasing dose at time of study entry.\n  * Patients with CNS metastatic disease will not be eligible for the phase 2 EWS and DSRCT cohorts.\n\n    * Participants 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 are eligible for this trial.\n    * The effects of PEEL-224 in combination with temozolomide and vincristine on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of PEEL-224 administration.\n    * Ability to understand and\u002For the willingness of the patient (or parent or legally authorized representative, if minor) to provide informed consent, using an institutionally approved informed consent procedure.\n    * Any participant must obtain prior approval from insurance to reimburse oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide.\n\nExclusion Criteria:\n\n* Patients who have received prior treatment with PEEL-224.\n* Patients who have had progressive disease while receiving irinotecan and temozolomide in combination will be excluded from the Phase 2 EWS and DSRCT cohorts only.\n* Participants who are receiving any other anti-cancer agents for this condition.\n* Patients receiving strong P450 CYP1A2 and CYP3A4 inhibitors and\u002For inducers with 14 days of the first planned dose of PEEL-224. NOTE: levofloxacin is permitted and preferred over ciprofloxacin for patients needing a fluoroquinolone.\n* Patients who have received a solid organ or allogeneic stem cell transplant\n* Pregnant participants, given that the effects of PEEL-224 on the developing human fetus are unknown.\n* Breastfeeding mothers, because there is an unknown risk for adverse events in nursing infants secondary to treatment of the mother with PEEL-224.\n* Patients with a history of allergic reactions attributed to PEGylated drugs, camptothecins, temozolomide or vincristine.\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","12 Years","49 Years",{"count":19,"type":20},63,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This research is being done to test a new drug called PEEL-224 in combination with two commercially available drugs, Vincristine and Temozolomide, and to determine how effective this combination of drugs is at treating Ewing Sarcoma (EWS) and Desmoplastic Small Round Cell Tumor (DSRCT), as well as multiple other kinds of sarcomas.\n\nThe names of the study drugs and biological agents involved in this study are:\n\n* PEEL-224 (a type of Topoisomerase 1 inhibitor)\n* Vincristine (A type of vinca alkaloid)\n* Temozolomide (A type of alkylating agent)\n* Pegfilgrastim or Filgrastim (types of Myeloid growth factors)",[27,28,29,30,31,32],"Sarcoma","Sarcoma, Ewing","Desmoplastic Small Round Cell Tumor","Refractory Sarcoma","Osteosarcoma","Rhabdomyosarcoma",[27,28,29,30,34,35,36],"Relapsed Sarcoma","osteosarcoma","rhabdomyosarcoma","RECRUITING","2026-02-17",{"date":40,"type":41},"2026-02-19","ACTUAL",{"date":43,"type":41},"2025-01-27",{"date":45,"type":20},"2029-09-01",{"name":47,"class":48},"David S Shulman, MD","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100545866","a-study-to-evaluate-the-utilization-of-3d-printed-models-in-pre-operative-planning-100545866","NCT06387485","A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning","Inclusion Criteria:\n\n1. Subjects must be at least 13 years of age.\n2. Subjects must have the ability to provide written informed consent.\n3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.\n4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women.\n2. Subjects that have a serious systemic pathology.\n3. Subjects that have clotting disorders.\n4. Subjects that have uncontrolled hypertension.\n5. Subjects that are HIV-positive.\n6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning.\n7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).\n8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.","13 Years",{"count":57,"type":20},150,[59],"NA","This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.\n\nPrimary endpoint: Operative time of surgical procedure.\n\nSecondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.\n\nExploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.",[28,62,31,63,64],"Chondrosarcoma","Fibrous Histiocytoma","Fibrosarcoma",[66],"bony tumor","2026-02-04",{"date":69,"type":41},"2026-02-06",{"date":71,"type":41},"2024-03-01",{"date":73,"type":20},"2027-07-31",{"name":75,"class":76},"Ricoh USA, Inc.","INDUSTRY",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":21,"phases":89,"briefSummary":90,"conditions":91,"keywords":99,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100598091","phase-1-sequential-infusion-of-cd146-targeted-and-her2-targeted-car-t-cells-in-patients-with-advanced-sarcomas-100598091","NCT07066982","Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","A Phase 1\u002F2 Open-Label, Multicenter Trial of Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas","BAH2573-103","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Diagnosis: Histologically or cytologically confirmed sarcoma (soft tissue or bone sarcoma), that is metastatic, locally advanced, or refractory to standard therapy. This may include osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, leiomyosarcoma, or other high-grade sarcomas. Patients must have evidence of measurable disease as per RECIST or applicable criteria.\n* Prior Treatment: Patients should have received and progressed on or not be candidates for standard first-line treatments. There is no limit on number of prior lines of therapy, but at least one prior systemic therapy for sarcoma is typically required (unless no standard therapy exists for the subtype). A minimum wash-out period (e.g. 2 weeks) from previous treatments (chemotherapy, radiation, or other immunotherapy) is required before lymphodepletion.\n* Age and Performance Status: Participants age 12 years and older (both adolescent and adult patients are eligible; for minors, legal guardian consent is required). Upper age limit of \\~75 years, or as determined by medical fitness. ECOG performance status 0-1 (or Karnofsky ≥70% for pediatric patients), indicating subjects are ambulatory and able to perform light work.\n* Organ Function: Adequate organ function to undergo cytotoxic chemotherapy and cell transfer therapy, including: cardiac ejection fraction ≥50%; baseline oxygen saturation \\>92% on room air; adequate bone marrow reserves (absolute neutrophil count ≥1.0×10\\^9\u002FL, platelets ≥75×10\\^9\u002FL, hemoglobin ≥8 g\u002FdL), hepatic function (e.g. bilirubin ≤1.5× ULN, AST\u002FALT ≤2.5× ULN), and renal function (e.g. creatinine clearance ≥50 mL\u002Fmin or age-appropriate normal).\n* Tumor Antigen Expression: Expression of CD146 and\u002For HER2 in the tumor is recommended (as assessed by immunohistochemistry or flow cytometry on a tumor sample). Note: At least one of the target antigens (CD146 or HER2) should be present on the tumor; if feasible, patients should have tumor tissue tested for these markers. (In cases where testing is unavailable, enrollment may proceed based on histology known to often express these targets, per investigator judgment.)\n* Consent: Ability to understand and provide written informed consent (or assent for minors with consent of legal guardian). Patients (or guardians) must be willing to comply with trial procedures and follow-up.\n\nExclusion Criteria:\n\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell therapy is excluded. Also exclude patients who received any investigational drug, immunotherapy (e.g. checkpoint inhibitor), or major surgery within a certain interval (e.g. 4 weeks) prior to enrollment. Concurrent enrollment in another interventional clinical trial is not allowed.\n* Recent Therapies: Prior treatment with any CAR-T cell therapy or other gene-modified T-cell Infections: Active uncontrolled infection, including active hepatitis B or C infection, or HIV infection with uncontrolled viral load. Patients must not have evidence of active tuberculosis or other severe infections. All patients will be screened for HBV, HCV, and HIV at baseline.\n* Immunosuppression: Use of systemic immunosuppressive medications (such as chronic corticosteroids at \\>10 mg prednisone daily or equivalent) within 7 days prior to leukapheresis. (Physiologic replacement doses of steroids are permitted.) Patients with a history of allogeneic stem cell transplant or solid organ transplant are excluded (due to the need for immunosuppression and risk of graft-versus-host or graft rejection).\n* Medical Comorbidities: Any significant uncontrolled medical condition that would, in the investigator's judgment, make the patient an unsuitable candidate for CAR-T therapy. For example: active autoimmune diseases requiring immunosuppression, clinically significant heart failure (NYHA class III-IV), unstable angina or myocardial infarction within 6 months, severe chronic respiratory disease requiring supplemental oxygen, or psychiatric conditions that would interfere with study participation and follow-up.\n* Pregnancy\u002FBreastfeeding: Women who are pregnant or breastfeeding are excluded due to unknown risks of the treatment to a fetus or infant. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception during the study and for a suitable period after CAR-T infusion (e.g. 1 year), given the potential for sustained CAR T-cell activity. A negative serum pregnancy test is required for females of childbearing potential before starting lymphodepletion.","21 Years","90 Years",{"count":88,"type":20},60,[23,24],"This is an open-label, non-randomized, multicenter Phase 1\u002F2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.",[27,92,28,93,94,95,96,97,98],"Sarcoma, Kaposi","Sarcoma,Soft Tissue","Sarcoma of Bone and Connective Tissue","Sarcoma, Synovial","Sarcoma Metastatic","Sarcomas, Germinoblastic","Sarcoma of Bone",[27,100,101,102,98],"CD146","HER2","CAR-T","2025-07-04",{"date":105,"type":41},"2025-07-15",{"date":107,"type":41},"2025-05-29",{"date":109,"type":20},"2028-12-28",{"name":111,"class":48},"Essen Biotech",1]