[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atrt-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atrt-recurrent":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100594313","early-phase-1-a-phase-01-study-of-cdna-for-tp53-checkpoint-inhibition-and-radiation-in-children-with-recurrent-progressive-or-refractory-cns-malignancies-100594313",false,"NCT07017816","A Phase 0\u002F1 Study of cDNA for TP53, Checkpoint Inhibition and Radiation in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB: Joint Administration of cDNA for TP53, checkpOint Inhibition and Boost\u002FHypofractionated Radiation. A Phase 0\u002F1 Study in Children With Recurrent, Progressive or Refractory CNS Malignancies.","JACOB","Inclusion Criteria:\n\n* Tumor\n\n  a. Patients must have a recurrent, progressive, or refractory CNS malignancy for which there are not known curative options.\n\n  i. Medulloblastoma, ATRT, High grade gliomas, pineoblastomas, embryonal tumors NOS, CNS sarcomas, ependymomas, other high-grade malignancies that failed first line therapies.\n\nii. Patients should have received radiation for standard up-front therapy. iii. Patients must have received at least one line of standard of care treatment without limitation to the number of treatments received. b. Evidence of clinical and\u002For radiological progressive disease as defined by RAPNO criteria.\n\nc. Patients with metastatic disease are eligible d. Patients must have available archival (formalin-fixed paraffin embedded) or fresh tumor tissue for correlative studies.\n\n* Patient Characteristics a. The first 3 patients will be \\>7 years old to \\\u003C22 years old i. Following initial successful treatment of the first 3 patients: Patients must be ≥3yrs and \\\u003C22 years of age.\n\n  b. Must have recovered from all surgical interventions prior to the start of the radiation and maintenance phases c. Patients must have a BSA of 0.6m2 or more to be enrolled. 3. Previous treatment\n  1. Patients must have recovered from the acute effects of prior therapy. Adverse events resulting from prior surgical intervention will not be an ineligibility criterion.\n  2. Chemotherapy: Patients must have received their last dose of known chemotherapy at least two (2) weeks prior to receipt of SGT-53.\n  3. Biologic therapy: Patients must have received their last dose of biological agent \\>7 days prior to receipt of SGT-53.\n  4. Radiation therapy: Patients must be deemed to be a reasonable candidate for hypofractionated irradiation from a clinical standard of care perspective.\n\n  i. At least 3 months from craniospinal radiation therapy, ii. Other substantial bone marrow irradiation ≥6 weeks prior to enrollment, iii. Local palliative XRT (small volume) ≥2 weeks. iv. if progressive disease is documented by radiological evidence of disease in areas not previously radiated, no minimum time required.\n\n  e. Corticosteroids: Patients who are receiving dexamethasone or other corticosteroids must be on a stable or decreasing dose for at least one (1) week prior to enrollment. There will be a maximum allowable steroid dose of 0.5mg\u002Fm2\u002Fday dexamethasone equivalents f. Growth factors: Patients must have received their last dose of any short acting growth factor at least one week prior to treatment, for long acting or pegylated growth factors, the last dose must be at least two (2) weeks prior to start of treatment.\n\n  4\\. Neurologic Status\n\n  a. Patients should be at their neurological baseline for a minimum of one week prior to enrollment.\n\n  5\\. Performance Status\n\n  a. Performance status (KarnofskyPS for \\>16yrs, or Lansky PS for \\\u003C16yrs) assessed within two weeks must be \\>50.\n\n  i. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for assessing the performance score.\n\n  6\\. Organ Function - Patients must have normal organ and marrow function as defined below:\n  1. Absolute neutrophil count \\>750\u002Ful\n  2. Platelets ≥75,000\u002Ful\n  3. Hemoglobin ≥8g\u002FdL (may be supported with transfusion)\n  4. Total bilirubin ≤1.5x ULN\n  5. ALT\u002FAST ≤3x ULN\n  6. Serum albumin ≥2g\u002FdL\n  7. Normal cardiac function defined as ejection fraction within normal limits for age and gender\n  8. a serum creatinine based on age\u002Fgender as below or a creatinine clearance or serum GFR ≥ 70ml\u002Fmin\u002F1.73m2: Serum Creatinine for age\u002Fsex Age Maximum Serum Creatinine (mg\u002FdL) Male Female\n\n     1. \\\u003C2 years 0.6 0.6\n     2. \\\u003C6 years 0.8 0.8\n\n     6-\\\u003C10 years 1 1 10-\\\u003C13 years 1.2 1.2 13- \\\u003C16 years 1.5 1.4 \\> 16 years 1.7 1.4 The threshold creatinine values in this table were adapted from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds 106:.522, 1985) utilizing child length and stature data published by the CDC.\n\n     7\\. Pregnancy prevention- all patients of childbearing or child fathering potential must be willing to use an acceptable form of birth control while being treated on this study and at least 5 months after receiving the last study treatment.\n\n     8\\. Pregnancy status: Female patients must not be pregnant or nursing. Female patients of reproductive potential must also have a negative serum pregnancy test at the time of enrollment.\n\n     9\\. Informed Consent - Patient and\u002For guardian have the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.\n\n     Exclusion Criteria:\n* 1\\. Low-grade-glioma, craniopharyngioma, and other non-malignant CNS tumors are excluded.\n\n  2\\. Patients with diagnosis of diffuse midline gliomas (DMGs) are excluded. 3. Patients with any clinically significant unrelated systemic illness (serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) that is likely to interfere with ability to tolerate study therapy or study procedure results.\n\n  4\\. Patients with pre-existing cardiac dysfunction defined as baseline EF of less than 35% 5. Patients with pre-existing pulmonary fibrosis, interstitial lung disease, and clinically significant pulmonary lung disease.\n\n  6\\. Patients who are receiving any other investigational drug therapy 7. Patients who in the opinion of the investigator cannot adhere to protocol requirements 8. Patients with history of autoimmune diseases that required treatment in the last 2 years are not eligible. Asymptomatic laboratory abnormalities (e.g. ANA, rheumatoid factor, altered thyroid function studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder. Replacement therapy (e.g. thyroxine, insulin or physiologic corticosteroid replacement therapy) is not considered a form of systemic treatment.\n\n  9\\. Patients who have received a live vaccine within 30 days of start of study treatment are not eligible.\n\n  10\\. Patients with known HIV\u002FAIDS or acute\u002Fchronic Hepatitis B or C are excluded.\n\n  11\\. Patients who are prohibited from receiving radiation therapy (reached maximum lifetime dose) are not eligible.","ALL","3 Years","21 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This clinical trial is studying a drug called SGT-53 along with radiation and another drug called Nivolumab. It's for children with brain tumors that have come back, gotten worse, or didn't get better with earlier treatments. The main questions it aims to answer are:\n\nWhat is the right dose of SGT-53 that children can safely receive when it is used with radiation and Nivolumab? This dose will be used in the second phase of the trial.\n\nWhat side effects are there of SGT-53 when it is used with radiation and Nivolumab?\n\nHow does SGT-53 move through the body when given with radiation and Nivolumab?\n\nHow much of the SGT-53 drug is found in the tumor tissue? This will be tested in a small group of patients?\n\nParticipants will:\n\nFor the first treatment cycle:\n\nGet SGT-53 twice per week Get Nivolumab every 2 weeks Receive radiation therapy during week 2\n\nFor Cycles 2-6:\n\nGet SGT-53 once per week during even cycles and twice per week during odd cycles Get Nivolumab every 2 weeks For Cycles 7+ Get both SGT-53 and Nivolumab every 2 weeks In the phase 0 part of the study, 4 participants will have genetic testing performed on their tumor tissue after receiving SGT-53. These samples will be compared to another sample taken from the skin.",[28,29,30,31,32,33,34],"CNS Malignancies","Medulloblastoma Recurrent","ATRT Recurrent","Pineoblastoma","Embryonal Neoplasm","Ependymoma Recurrent","High Grade Gliomas","RECRUITING","2026-04-24",{"date":38,"type":39},"2026-04-29","ACTUAL",{"date":41,"type":39},"2025-12-16",{"date":43,"type":22},"2028-05-01",{"name":45,"class":46},"Children's National Research Institute","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100160063","phase-2-antiangiogenic-therapy-for-children-with-recurrent-medulloblastoma-ependymoma-atrt-and-rare-cns-tumors-100160063","NCT01356290","Antiangiogenic Therapy for Children With Recurrent Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors","A Phase II Study of Metronomic and Targeted Anti-angiogenesis Therapy for Children With Recurrent\u002FProgressive Medulloblastoma, Ependymoma, ATRT and Rare CNS Tumors","MEMMAT","Inclusion criteria for patients Stratum I: Relapsed or progressive medulloblastoma - completed Stratum II: Relapsed or progressive ependymoma (at least one site of untreated recurrent disease) Stratum III: Relapsed or progressive ATRT (at least one site of untreated recurrent disease) Stratum IV: Relapsed or progressive medulloblastoma (at least one site of untreated recurrent disease) Stratum V: Relapsed or progressive CNS tumor of various histologies or patients with exclusion criteria or adult patients (explorative) Histological confirmation at diagnosis or relapse Stratum IV: Confirmation of the medulloblastoma group by methylation; IDAT (Intensity Data; raw data of methylation array) Female or male, aged from 0 to \\\u003C20 years (at time of original diagnosis) Participants must have normal organ and bone marrow function (ALT \\\u003C5x institutional upper limit of normal, creatinine \\\u003C1.5x institutional upper limit of normal for age, WBC \\>1000\u002Fmm3, platelets \\> 20,000\u002Fmm3. Patients with values less than WBC 2000\u002Fmm3 or platelets 50,000\u002Fmm3 will require initiation of treatment with etoposide and cyclophosphamide at a lower starting dose as defined within the protocol Karnofsky performance status ≥50. For infants and children less than 12 years of age, the Lansky play scale ≥50% will be used Written informed consent of patients and \u002F or legal guardian\n\nExclusion criteria for patients VP- or subdural peritoneal shunt dependency (can be included in Stratum V) Prior treatment with temozolomide\u002Firinotecan (can be included in Stratum V) Active infection, pregnancy or breast feeding Treatment for current relapse (surgery may be performed before MEMMAT treatment; patients with sites of disease not irradiated are still eligible for the protocol) Known hypersensitivity to any of the drugs in the protocol Active peptic ulcer Any significant cardiovascular disease not controlled by standard therapy e.g. systemic hypertension Anticipation of the need for major elective surgery during the course of the study treatment Any disease or condition that contraindicates the use of the study medication\u002Ftreatment or places the patient at an unacceptable risk of experiencing treatment-related complications Non-healing surgical wound A bone fracture that has not satisfactorily healed","19 Years",{"count":58,"type":22},232,[60],"PHASE2","Patients with with recurrent or progressive medulloblastoma, ependymoma, atypical teratoid rhabdoid tumor (ATRT), and CNS tumors of various histologies have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities.\n\nAntiangiogenesis therapy has emerged as a new treatment option in solid malignancies. The frequent delivery of low doses of chemotherapy, referred to as metronomic or antiangiogenic chemotherapy, targets endothelial cells while reducing the toxicity associated with standard dose chemotherapy.\n\nThe aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma, ATRT, and CNS tumors of various histologies, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life.\n\nThe study will be conducted in independent strata. Stratum I (recurrent medulloblastoma): recently completed (Peyrl, 2023). Stratum II (recurrent ependymoma), III (recurrent ATRT) and V (recurrent CNS tumors of various histologies, patients with exclusion criteria and adult patients): The primary objective is to determine the response rate defined as the percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or lack of recurrence at 6 months after start of antiangiogenic treatment. Stratum IV (recurrent medulloblastoma): To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt. Additionally, PFS, OS, toxicity, QoL, performance status, predictive and prognostic markers will be examined.\n\nIn stratum II and III, the study will follow an open label, single arm phase 2 design, and an open label randomized two-arm phase 2 design in Stratum IV, and the exploratory Stratum V.",[29,33,30,63],"Rare CNS Tumor Recurrent",[65,66,67,68,69,70,71,72,73],"Medulloblastoma","Ependymoma","ATRT","Relapse","Children","antiangiogenic","metronomic","intraventricular","Rare CNS tumor","2026-02-19",{"date":76,"type":39},"2026-02-23",{"date":78,"type":39},"2014-04",{"date":80,"type":22},"2030-04",{"name":82,"class":46},"Medical University of Vienna",22]