[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"solid-tumor-childhood\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:solid-tumor-childhood":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100321494","phase-1-trial-of-nivolumab-following-partially-human-leukocyte-antigen-hla-mismatched-bmt-in-children--adults-with-sarcoma-100321494",false,"NCT03465592","Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma","Single-arm, Open-label, Phase 1b\u002F2 Trial of Nivolumab Therapy Following Partially HLA Mismatched (Haploidentical) Bone Marrow Transplant in Children and Young Adults With High Risk, Recurrent or Refractory Sarcomas","Inclusion Criteria:\n\n1. Patients must be ≥ 12 months and ≤ 50 years of age at the time of study enrollment.\n2. Patients with histologically confirmed solid tumors with an estimated poor long term survival.\n3. Performance Level: Karnofsky ≥ 50% for patients \\> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age.\n4. Patients must be post RIC haploidentical BMT.\n5. Patients must have fully recovered from the acute toxic effects of prior BMT.\n6. Concomitant radiation therapy can be administered in the setting of this trial.\n7. Subjects must consent to allow for a baseline tumor biopsy. If a biopsy is not feasible, then archival tumor material must be made available. Tumor biopsies to be taken (if a subject's tumor is thought to be reasonably safe and easy to biopsy) at baseline (any time prior to the first dose after eligibility is met) and at Cycle 2 (4-6 cores per time point) or when lesions are visualized on physical examination or imaging studies in the case of no identifiable masses at cycle 2. Additional optional biopsies may be obtained later in the course of study treatment. The proposed investigation is considered a non-significant risk (NSR). A significant risk procedure is generally considered to be one for which the procedure-associated absolute risk of mortality or major morbidity, in the patient's clinical setting and at the institution completing the procedure, is 2% or higher. Diagnostic Tissue Samples Tissue, fluid, or blood may be collected from standard of care procedures used to treat or diagnose immune related toxicities\u002FGVHD.\n8. Organ Function Requirements:\n\n   I. Adequate Hematologic Parameters:\n   1. For patients with solid tumors without known bone marrow involvement:\n\n      * Peripheral absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n      * Platelet count ≥ 50,000\u002Fmm3\n   2. Patients with known bone marrow metastatic disease will be eligible for study without the above criteria. They may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions. These patients will not be evaluable for hematologic toxicity.\n\n   II. Adequate Renal Function Defined as:\n   1. Creatinine clearance or radioisotope Glomerular filtration rate (GFR) ≥ 70ml\u002Fmin\u002F1.73 m2 or\n   2. A serum creatinine based on age\u002Fgender as follows:\n\n      * Age 1 to \\\u003C2 years, Male: 0.6 and Female: 0.6\n      * Age 2 to \\\u003C6 years, Male: 0.8 and Female: 0.8\n      * Age 6 to \\\u003C10 years, Male: 1 and Female:1\n      * Age 10 to \\\u003C13 years, Male: 1.2 and Female 1.2\n      * Age 13 to \\\u003C16 years, Male: 1.5 and Female 1.4\n      * Age ≥ 16 years, Male: 1.7 and Female 1.4\n\n   III. Adequate Liver Function Defined as:\n   1. Bilirubin (sum of conjugated + unconjugated) ≤1.5 x upper limit of normal (ULN) for age\n   2. Serum glutamic pyruvic transaminase (SGPT) (ALT) ≤110 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n9. Patients must have been registered on protocol J12106 \"A Phase II Trial of Reduced Intensity Conditioning and HLA-matched or Partially HLA-mismatched (HLA-haploidentical) Related Donor Bone Marrow Transplant for High-risk Solid Tumors\" before enrolling on this study.Patient may be screened prior to Day +120 but first dose of study drug must be given on or after Day +120.\n\nExclusion Criteria:\n\n1. GVHD: any history of Stage 4 skin GVHD or Stage 3 gut\u002Fliver GVHD (a.k.a. overall Grade III\u002FIV GVHD) or any severe chronic GVHD. Any person with ≤ Grade II GVHD must be off systemic immunosuppressive therapy for at least 2 weeks prior to receiving Nivolumab therapy.\n2. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active auto- or allo-immune disease\n3. BMT-related toxicities: patients who developed idiopathic pneumonia syndrome (IPS) or veno-occlusive hepatic disease (VOD) must be off systemic immunosuppression and\u002For defibrotide for at least 14 days to be eligible.\n4. Infection: Patients who have an uncontrolled infection.\n5. 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.\n6. Has active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n7. Allergies and Adverse Drug Reaction\n\n   1. History of allergy to study drug components.\n   2. History of severe hypersensitivity reaction to any monoclonal antibody.\n8. Pregnancy or Breast Feeding: Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 5 months after the last dose of study treatment {i.e., 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo approximately five half-lives. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment {i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five half-lives.","ALL","12 Months","40 Years",{"count":20,"type":21},39,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This research is being done to find out if an investigational drug, Nivolumab, can be safely administered after a \"half-matched\" (haplo) bone marrow transplant (BMT), and if the investigational drug will help to prevent or delay relapse or progression of sarcomas. In this study investigators will also be trying to learn more about how the investigational drug changes blood and\u002For tumors. Participants are eligible for this trial if they have recently undergone a \"half-matched\" (haplo) bone marrow transplant and have either relapsed or are at high risk to relapse.",[28,29,30],"Sarcoma","Solid Tumor, Adult","Solid Tumor, Childhood","RECRUITING","2026-02-03",{"date":34,"type":35},"2026-02-05","ACTUAL",{"date":37,"type":35},"2018-05-01",{"date":39,"type":21},"2029-03",{"name":41,"class":42},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","OTHER",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100476251","an-exploratory-study-to-evaluate-immune-determinants-of-the-response-to-adoptive-cell-therapy-act-in-solid-and-hematologic-tumors-100476251","NCT05481502","An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors","A Prospective Trial to Evaluate Immune Determinants of the Response and the Toxicity to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors","PIONEER","Inclusion Criteria:\n\n* Patient affiliated to a social security regimen\n* Tumor lesion accessible to core biopsies\n* Patient who is fully informed, able to comply with the protocol and who signed the informed consent\n* Pediatric patients \\> than 2 years old can be included\n* No restriction about the Eastern Cooperative Oncology Group (ECOG) status\n\nExclusion Criteria:\n\n* Coagulation abnormality prohibiting a biopsy (but patients can still give their consent for blood and bone marrow samples).\n* Tumor lesion not accessible to core biopsies.\n* Pregnant or nursing women cannot participate in this study.","2 Years",{"count":54,"type":21},160,[56],"NA","This is a study to explore the phenotypic and transcriptional changes of different cellular components in the tumor following the injection of somatic cell therapy drugs.\n\nThe second objective is to explore phenotypic and transcriptional changes of different cellular components in blood and bone marrow following injection of somatic cell therapy drugs.Then correlate the phenotypic and transcriptional profile of different tumor, blood and bone marrow immune populations with clinical response and\u002For toxicity. And to finish this study is designed in order to identify a phenotypic, transcriptional and epigenetic profile of intra-tumoral adoptive cells and correlate this profile with clinical response and\u002For toxicity.",[29,30,59],"Hematologic Cancer","2025-06-23",{"date":62,"type":35},"2025-06-24",{"date":64,"type":35},"2022-06-08",{"date":66,"type":21},"2027-07-01",{"name":68,"class":42},"Gustave Roussy, Cancer Campus, Grand Paris",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":76,"enrollmentInfo":77,"targetDuration":79,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100487946","multicenter-prospective-observational-study-for-early-diagnosis-and-development-of-follow-up-protocol-and-hearing-rehabilitation-program-for-ototoxic-hearing-loss-after-chemotherapy-for-pediatric-solid-cancer-100487946","NCT05633719","Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer","Inclusion Criteria:\n\n① Solid cancer patients under the age of 19 receiving Platinum chemotherapy\n\n② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy\n\nExclusion Criteria:\n\n① Those who have received chemotherapy or radiation in the past\n\n* Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial","19 Years",{"count":78,"type":21},300,"1 Year","OBSERVATIONAL","More than half of all pediatric cancer in Korea are solid cancer. For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded. Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing. Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors. by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.",[30],[84],"Pediatric solid tumor, Chemotherapy, Hearing loss","NOT_YET_RECRUITING","2022-11-21",{"date":88,"type":35},"2022-12-01",{"date":88,"type":21},{"date":91,"type":21},"2026-06-30",{"name":93,"class":42},"Seoul National University Hospital"]