[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-medulloblastoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-medulloblastoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,71,97,124,158,196],{"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":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100053855","phase-1-a-study-of-177lu-dtpa-omburtamab-in-children-and-adolescents-with-brain-cancer-or-cancer-that-has-spread-to-the-central-nervous-system-cns-100053855",false,"NCT07698899","A Study of 177Lu-DTPA-Omburtamab in Children and Adolescents With Brain Cancer or Cancer That Has Spread to the Central Nervous System (CNS)","A Phase I Dose Escalation Trial of Compartmental Radioimmunotherapy (cRIT) Using 177Lu-DTPA-omburtamab in Pediatric and Adolescent Patients With Recurrent or Refractory B7H3 Expressing Primary or Metastatic CNS Tumors","Inclusion Criteria:\n\n\\- Disease type:\n\n* Histologically confirmed diagnosis of a tumor that is known to express B7-H3 including but not limited to neuroblastoma, medulloblastoma, rhabdoid tumors, pineoblastoma, retinoblastoma, CNS embryonal tumor, rhabdomyosarcoma, Ewing's sarcoma and ependymoma.\n\n  * Disease status:\n* Patients must have recurrent or refractory disease with CNS parenchymal and\u002For leptomeningeal disease which has been treated with conventional therapies or for which no conventional therapy exists. Measurable or evaluable disease is not required at time of enrollment.\n\n  \\- Age: Patients must be ≥ 3 and \\\u003C 22 years of age at the time of enrollment.\n  * Prior Therapy: The participant must have recovered from acute toxic effects of prior anti-cancer therapies with the following minimum duration from prior therapy:\n* Chemotherapy: Patients must have received their last dose of known myelosuppressive anticancertherapy at least 21 days (3 weeks) prior to enrollment or at least 42 days (6 weeks) if prior nitrosourea.\n* Anti-GD2 monoclonal antibody (neuroblastoma patients): Patients must have received their last dose of anti-GD2 mAb at least 14 days (2 weeks) before enrollment.\n* Radiation: Patients must have had their last fraction of:\n\n  * Craniospinal irradiation, whole brain radiation, or total body irradiation at least 21 days (3 weeks) prior to study enrollment.\n  * Focal radiation to areas of symptomatic metastatic disease at least 14 days (2 weeks) prior to study enrollment.\n* Stem Cell Transplant (SCT): For autologous SCT, 60 days (≥ 2 months) must have elapsed before study enrollment. Patients who have received an autologous hematopoietic stem cell injection to support non- myeloablative therapy (such as 131 I-MIBG) are eligible at any time as long as they meet the other criteria for eligibility. 131\n* I-MIBG therapy or treatment with other radiopharmaceuticals (neuroblastoma 131 patients): A minimum of 42 days (6 weeks) must have elapsed after I-MIBG therapy before start of protocol therapy.\n* Investigational\u002FBiologic Agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days (1 week) prior to study enrollment.\n* Molecular targeted therapies: Patients must complete a washout period from last therapy that is either 7 days (1 week) or 3 half-lives, whichever is longer.\n\n  * Patients with neurological deficits should have deficits that are stable for a minimum of 7 days (1 week) prior to enrollment.\n  * Patients with seizure disorders may be enrolled if seizures are controlled.\n  * Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within 14 days (2 weeks) prior to study enrollment must be ≥ 50%.\n* Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\n  * Peripheral absolute neutrophil count (ANC) ≥ 0.5x 109\u002F L (must not have received G-CSF within 7 days (1 week) prior to enrollment or pegfilgrastim within 14 days (2 weeks) prior to enrollment.\n  * Platelet count ≥ 75 x 109\u002F L. Growth factor support (romiplostim or biosimilar) is permitted both prior to and during therapy.\n* For patients with neuroblastoma (regardless of marrow disease status) and other solid tumors known bone marrow infiltration from disease: platelet count ≥ 50 x 109\u002F L (with no platelet transfusion within 7 days prior to study enrollment).\n\n  \\- Adequate Renal Function Defined as:\n\n  \\- A creatinine based on age\u002Fgender as follows: Age; Maximum Serum Creatinine (mg\u002FdL) Male and Female\n\n  1 month to \\\u003C 6 months; 0.4, 0.4 6 months to \\\u003C 1 year; 0.5, 0.5\n  1. to \\\u003C 2 years; 0.6, 0.6\n  2. to \\\u003C 6 years; 0.8, 0.8\n\n  6 to \\\u003C 10 years; 1, 1 10 to \\\u003C 13 years; 1.2. 1.2 13 to \\\u003C 16 years; 1.5, 1.4\n\n  ≥ 16 years; 1.7, 1.4\n  * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.\n  * Adequate Liver Function Defined as: - Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (or ≤ 3 x ULN if Gilbert's syndrome) - SGPT (ALT) \\\u003C 135 U\u002FL. For the purpose of this study, the ULN for SGPT is 45 U\u002FL.\n  * Presence of an appropriate intraventricular access device (e.g., programmable ventriculoperitoneal \\[VP\\] shunt or Ommaya reservoir). Patients are not required to have an existing programmable VP shunt or Ommaya at the time of study enrollment but must be willing and able to undergo a surgical procedure to have one placed prior to cRIT.\n* Note: Patients with an existing intraventricular VP shunt without a programmable component must be willing and able to undergo modification of the shunt.\n\n  * Patients may have active malignancy outside the central nervous system but do not immediately require treatment for systemic disease. Neuroblastoma patients with CNS and systemic disease will only receive 1 dose of cRIT 177Lu- omburtamab while patients with CNS metastases in the absence of systemic disease can receive 2 doses of cRIT 177Lu-omburtamab.\n  * Patients may be on standing steroids, as long as the dosage is either stable or decreasing for at least 7 days (1 week) prior to enrollment.\n  * Human Anti-Mouse Antibody (HAMA) testing will be performed prior to 177Lu-DTPAomburtamab.\n\nExclusion Criteria:\n\n* Patients with obstructive or symptomatic communicating hydrocephalus.\n* Patients with an uncontrolled life-threatening infection.\n* Patients who are pregnant:\n\n  o A negative pregnancy test is required for all women of childbearing age, and appropriate contraception for 3 months after the last dose of 177Lu-DTPAomburtamab is required during the study period.\n* Severe major organ toxicity:\n\n  * Cardiac, pulmonary, and gastrointestinal system toxicity should all be \\\u003C grade 2\n  * Patients with grade 4 hearing loss are excluded","ALL","3 Years","22 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of this study is to find out whether 177Lu-DPTA-omburtamab is a safe treatment for children and adolescents with recurrent\u002Frefractory medulloblastoma or another type of cancer with CNS metastases.",[27,28,29,30],"Recurrent Medulloblastoma","Refractory Medulloblastoma","CNS Metastases","Central Nervous System Metastasis",[27,28,29,30,32,33,34],"Memorial Sloan Kettering Cancer Center","26-097","177Lu-DTPA-Omburtamab","RECRUITING","2026-07-09",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-07-02",{"date":43,"type":21},"2030-07-02",{"name":32,"class":45},"OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100630795","phase-1-rna-lipid-particle-rna-lp-vaccines-for-recurrentprogressive-medulloblastoma-mb-100630795","NCT07492316","RNA-lipid Particle (RNA-LP) Vaccines for Recurrent\u002FProgressive Medulloblastoma (MB)","A Phase I\u002FII Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM), and Recurrent\u002FProgressive Medulloblastoma (MB)","PNOC020 rMB","Inclusion Criteria:\n\n* Age \\> 3 and \\\u003C\u002F= 39 years.\n* Histologically confirmed or suspected recurrent\u002Fprogressive MB in first or second relapse.\n* Patients must have received radiation therapy as part of prior therapy.\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Prior Therapy: Patients must have fully recovered from all 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  * XRT\u002FExternal Beam Irradiation, including Protons: ≥ 90 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis.\n  * Other therapeutic clinical trials: ≥ 14 days after last dose of investigational agent, unless otherwise defined above.\n  * Patients must not have received prior exposure to pp65-directed therapy or any RNA-LP therapy.\n* A diagnostic contrast-enhanced MRI of the brain and spine must be performed preoperatively, and diagnostic contrast-enhanced MRI of the area biopsied or resected must be performed postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery.\n* Performance Score: Karnofsky ≥ 60 for participants \\> 16 years of age and Lansky ≥ 60 for participants \\\u003C 16 years of age (See Appendix A) assessed within 2 weeks prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  d. ANC (Absolute neutrophil count) ≥ 1,000\u002Fμl (unsupported) e. Platelets ≥ 100\u002Fμl (unsupported for at least 7 days) f. Hemoglobin \\> 8 g\u002FdL (may be supported)\n* Renal: Creatinine clearance or radioisotope GFR ≥ 70mL\u002Fmin\u002F1.73 m2\n* Hepatic:\n\n  d. Bilirubin ≤ 3 times upper limit of institutional normal for age. e. SGPT (ALT) ≤ 5 times upper limit of institutional normal for age. f. SGOT (AST) ≤ 5 times upper limit of institutional normal for age.\n* Participants who are receiving systemically-administered steroids must be on a stable or decreasing dose for \\>1 week prior to enrollment. The patient steroid dose should be no more than a dexamethasone-equivalent of 2.8 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy for management of pituitary\u002Fadrenal axis insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed.\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations\n* A legal parent\u002Fguardian or patient must be able to understand and be willing to sign a written informed consent document\n* For women of childbearing potential (WOCBP), negative serum\u002Furine pregnancy test at enrollment\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug.\n* Males of child-fathering potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC020 if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\n* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+\n* Bulky disease, defined as:\n\n  * Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine\n  * Tumor with extensive and diffuse multilobular involvement (\\>3 lobes)\n  * Tumor with extracranial disease (with the exception of spinal metastases in Stratum 3)\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Uncontrolled seizure disorder\n* History of myocarditis\n* Receipt of any live vaccine within 30 days prior to enrollment\n* Known active infection or immunosuppressive disease.\n* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.\n* Severe or unstable concurrent medical conditions.\n* Women must not be pregnant or breast-feeding.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.","4 Years","39 Years",{"count":57,"type":21},24,[24],"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in pediatric patients with recurrent\u002Fprogressive Medulloblastoma (MB)",[27],"2026-06-26",{"date":63,"type":39},"2026-06-29",{"date":65,"type":39},"2026-04-24",{"date":67,"type":21},"2031-03-31",{"name":69,"class":45},"University of Florida",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":70},"100641866","parental-distress-and-treatment-adherence-in-pediatric-recurrent-medulloblastoma-100641866","NCT07660458","Parental Distress and Treatment Adherence in Pediatric Recurrent Medulloblastoma","Parental Distress as a Predictor of Treatment Adherence in Pediatric Recurrent Medulloblastoma: A Prospective Longitudinal Cohort Study","Inclusion Criteria(Children):\n\n* Diagnosis of medulloblastoma with documented recurrence (radiographic or histopathological confirmation)\n* Age ≤ 18 years at enrollment\n* Currently receiving active treatment for recurrent disease\n* Life expectancy ≥ 3 months\n\nInclusion Criteria (Parents\u002FCaregivers):\n\n* Primary caregiver responsible for medication administration and treatment coordination\n* Age ≥ 18 years\n* Able to read and understand study materials in \\[English\\]\n* Willing to complete study assessments\n\nExclusion Criteria:\n\n* Child receiving exclusively palliative\u002Fhospice care\n* Parent with severe psychiatric illness or cognitive impairment preventing informed consent or questionnaire completion\n* Child enrolled in another interventional trial that would confound adherence measurement","0 Years","18 Years",{"count":81,"type":21},450,"OBSERVATIONAL","Children with medulloblastoma, an aggressive brain tumor, require prolonged and complex multimodal therapy. Their primary parental caregivers bear the main responsibility for ensuring treatment adherence, yet the psychological toll on these caregivers may undermine their ability to follow prescribed regimens. This study investigates whether multidimensional parental distress predicts overall treatment adherence in this population, and which specific distress domains are most strongly associated with poor adherence.\n\nParental distress-including depression, anxiety, and posttraumatic stress-is common among parents of children with cancer and may interfere with their ability to manage complex treatment regimens. However, no study has specifically examined whether parental distress predicts treatment adherence in children with recurrent medulloblastoma, a devastating brain tumor with a poor prognosis and no standard treatment protocol.\n\nThis prospective longitudinal cohort study aims to investigate whether parental distress is a significant predictor of treatment adherence in children with recurrent medulloblastoma. A total of 450 parent-child dyads will be enrolled across 4 tertiary pediatric oncology centers. Children must have a confirmed diagnosis of recurrent medulloblastoma and be receiving active treatment. Parents (primary caregivers) will complete validated questionnaires at baseline assessing depression, anxiety, stress, and trauma-related distress using the DASS-21 and IES-R. Treatment adherence will be monitored over a 12-month follow-up period using electronic medication monitoring caps, clinic attendance records, and parent-reported medication logs.\n\nThe primary outcome is the proportion of prescribed chemotherapy doses taken (treatment adherence rate). Secondary outcomes include trajectories of adherence over time and the relationship between specific dimensions of parental distress (depression, anxiety, stress, posttraumatic stress) and adherence patterns. The study will also examine whether child clinical factors (e.g., molecular subgroup, prior treatment history) and family demographic factors moderate this relationship.\n\nFindings from this study may inform the development of targeted psychosocial interventions to support distressed parents and improve treatment adherence-and ultimately clinical outcomes-in this vulnerable pediatric population. Participants can expect to be enrolled in the study for approximately 12 months.",[85,27],"Medulloblastoma",[87],"Pediatric Brain Tumor；Parental Distress；Treatment Adherence；Psycho-Oncology；Caregiver Stress","2026-06-16",{"date":90,"type":39},"2026-06-22",{"date":92,"type":39},"2025-06-01",{"date":94,"type":21},"2026-07-30",{"name":96,"class":45},"West China Hospital",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100446672","phase-2-pep-cmv-vaccine-targeting-cmv-antigen-to-treat-newly-diagnosed-pediatric-hgg-and-dipg-and-recurrent-medulloblastoma-100446672","NCT05096481","PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma","Phase 2 Trial of a Novel Peptide Vaccine (PEP-CMV) Targeting CMV Antigen for Newly Diagnosed Pediatric High-grade Glioma and Diffuse Intrinsic Pontine Glioma and Recurrent Medulloblastoma","Inclusion Criteria for patients with recurrent \u002Fprogressive medulloblastoma (stratum I)\n\n1. Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment\n2. Diagnosis: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological verification of a medulloblastoma, at original diagnosis or relapse.\n\n   • Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI.\n3. Metastatic Disease: Patients with M+ disease are eligible.\n4. Performance Status:\n\n   Karnofsky ≥ 50% for patients \\>16 years of age or Lansky ≥ 50 for patients ≤ 16 years of age. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Prior Therapy:\n\n   1. Radiotherapy: prior radiotherapy requirements Patients must have received prior disease-directed therapy including radiotherapy for their initial diagnosis of medulloblastoma unless patients are less than 4 years of age at the time of enrollment.\n\n      For those less than 4 years of age at the time of enrollment, prior disease directed therapy does not have to include prior radiotherapy.\n\n      Patients must have had their last fraction of:\n      * Craniospinal irradiation, total body irradiation or radiation to ≥ 50% of pelvis \\> 3 months prior to enrollment.\n      * Focal irradiation \\> 4 weeks prior to enrollment\n   2. Myelosuppressive anticancer therapy: Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days prior to enrollment\n   3. Immunotherapy: Patients must have received their last dose of any immunotherapy agents at least 30 days prior to enrollment\n   4. Non-myelosuppressive anticancer agents: Patients must have received their last dose of non-myelosuppressive anticancer agents at least 7 days prior to study enrollment.\n   5. Antibodies: Patients must have received their last dose of any antibodies at least 21 days prior to enrollment.\n   6. Hematopoietic growth factors: Patients must have received their last dose of hematopoietic growth factors at least 14 days prior to enrollment for a long-acting growth factor (e.g. pegfilgrastim) or 7 days prior to enrollment for short-acting growth factor.\n   7. Autologous stem cell infusion: At least 90 days must have elapsed after an autologous stem cell infusion\n6. Organ Function Requirements:\n\n   1. Adequate bone marrow function defined as:\n\n      * ANC (Absolute neutrophil count) ≥ 1000\u002Fµl.\n      * Platelets ≥ 100,000\u002Fµl. (may be supported)\n      * Hemoglobin \\> 8 g\u002FdL. (may be supported)\n   2. Adequate Renal Function defined as: Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 or A serum creatinine based on age\u002Fgender as follows:\n\n      Age: Maximum Serum Creatinine (mg\u002FdL)\n      * 2 to \\\u003C 6 years: 0.8 (Male) 0.8 (Female)\n      * 6 to \\\u003C 10 years: 1 (Male) 1 (Female)\n      * 10 to \\\u003C 13 years: 1.2 (Male) 1.2 (Female)\n      * 13 to \\\u003C 16 years: 1.5 (Male) 1.4 (Female)\n      * ≥ 16 years: 1.7 (Male) 1.4 (Female)\n   3. Adequate Liver Function Defined as\n\n      * Total bilirubin ≤1.5 times institutional ULN\n      * AST(SGOT) ≤3 × institutional upper limit of normal\n      * ALT(SGPT) ≤3 × institutional upper limit of normal\n   4. Adequate Neurological Function Defined as\n\n      * Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to enrollment.\n      * Patients with current seizure disorders may be enrolled if seizures are well- controlled on antiepileptic therapies.\n   5. Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for three months after drug cessation.\n   6. Signed informed consent according to institutional guidelines must be obtained prior to enrollment.\n\nInclusion Criteria for Patients with Newly-Diagnosed High-Grade Gliomas (HGG) (stratum II, NOT CURRENTLY ENROLLING) and Newly-Diagnosed (DIPG) (stratum III)\n\n1. Age: Patients must be ≥3 and ≤39 years of age at the time of study enrollment\n2. Diagnosis\n\n   1. Stratum II (NOT CURRENTLY ENROLLING): patients must have histologically confirmed, newly-diagnosed HGG (such as anaplastic astrocytoma, glioblastoma, H3K27-altered DMG).\n\n      * Patients with a newly-diagnosed HGG must enroll within 6 weeks of their final dose of standard radiation therapy with or without chemotherapy.\n      * Patients with primary spinal cord tumors are eligible\n   2. Stratum III: Patients with a newly-diagnosed DIPG:\n\n      * Patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2\u002F3 of the pons, are eligible without histologic confirmation.\n      * Patients with brainstem lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of an infiltrating astrocytoma WHO grades II-IV.\n3. Metastatic Disease: Patients with M+ disease are eligible.\n4. Performance Status:\n\n   Karnofsky ≥ 50 for patients \\> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Prior Therapy requirements: Patients must have received no prior therapy other than surgery, radiation, chemotherapy during radiotherapy and\u002For steroids (dexamethasone with goal to wean dexamethasone throughout protocol therapy).\n\n   Patients with a newly diagnosed high-grade glioma or DIPG must enroll within 6 weeks of their final dose of standard of care radiation therapy with or without chemotherapy.\n   1. Patients with HGG or DIPG are permitted, but not required, to have received chemotherapy during radiation. Bevacizumab is permitted prior to enrollment in patients with DIPG or HGG. Patients must have received their last dose of bevacizumab at least 14 days prior to enrollment.\n   2. For HGG patients, Patients must have received radiotherapy at a standard dose of 54-59.4 Gy in 1.8 Gy fractions for approximately 6 weeks with an acceptable variance of 10%. Radiation therapy must have begun no later than 42 days after the date definitive surgery.\n   3. For patients with DIPG, Patients must have received radiotherapy at a standard dose of radiotherapy of 54 Gy in 1.8 Gy daily fractions for approximately 6 weeks with an acceptable variance rate of 10%. Radiation therapy must have begun no later than 42 days after the date of radiographic diagnosis or biopsy\n   4. For patients with spinal cord HGG: Patients must have received radiotherapy at a standard dose of 45-54 Gy in 1.8 Gy fractions for approximately 6-7 weeks with an acceptable variance of 10%\n   5. For patients with metastatic disease: Patients may have received standard dose CSI\n6. Organ Function Requirements:\n\n   1. Adequate bone marrow function defined as • ANC (Absolute neutrophil count) ≥ 1000\u002Fµl.\n\n      • Platelets ≥ 100,000\u002Fµl. (may be supported)\n\n      • Hemoglobin \\> 8 g\u002FdL. (may be supported)\n   2. Adequate Renal Function defined as: Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m2 or A serum creatinine based on age\u002Fgender as follows:\n\n      Age: Maximum Serum Creatinine (mg\u002FdL)\n\n      • 2 to \\\u003C 6 years: 0.8 (Male) 0.8 (Female)\n\n      • 6 to \\\u003C 10 years: 1 (Male) 1 (Female)\n\n      • 10 to \\\u003C 13 years: 1.2 (Male) 1.2 (Female)\n\n      • 13 to \\\u003C 16 years: 1.5 (Male) 1.4 (Female)\n\n      • ≥ 16 years: 1.7 (Male) 1.4 (Female)\n   3. Adequate Liver Function Defined as:\n\n      • Total bilirubin ≤1.5 times institutional ULN\n      * AST(SGOT) ≤3 × institutional upper limit of normal\n      * ALT(SGPT) ≤3 × institutional upper limit of normal\n   4. Adequate Neurological Function Defined as:\n\nPatients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n\nd. Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study.\n\ne. Signed informed consent according to institutional guidelines must be obtained prior to registration and for 3 months after drug cessation.\n\nExclusion Criteria for all strata:\n\n1. Pregnancy or Breast-Feeding:\n\n   1. Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls who are post-monarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n   2. Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for 3 months after drug cessation.\n2. Study Specific:\n\n   1. Active infection requiring treatment\n   2. Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history\n   3. Known immunosuppressive disease\n   4. Patients with active renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen, medications) and\u002For limiting activities of daily living (generally CTCAE Grade 2 or higher) or shortness of breath with limited exertion are not eligible. Pulmonary conditions include (but are not limited to) COPD, asthma, and hemi-pneumectomy\n   5. Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.\n   6. Patients receiving concomitant tumor-directed therapy\n   7. Patients receiving any other investigational drug therapy.\n   8. Patients on dexamethasone \\> 0.1 mg\u002FKg\u002Fday up to maximum dose of 4 mg\u002Fday or equivalent.\n   9. Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction).\n   10. Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy\n   11. Patients at high risk for imminent neurologic decline due to extensive bulk disease, midline shift, or herniation on MRI. These patients should be discussed with the study chairs.",{"count":105,"type":21},120,[107],"PHASE2","This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).\n\nPEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51.\n\nFunding Source - FDA OOPD",[110,111,27],"High Grade Glioma","Diffuse Intrinsic Pontine Glioma",[110,111,27,113],"Immunotherapy","2026-05-07",{"date":116,"type":39},"2026-05-11",{"date":118,"type":39},"2024-07-18",{"date":120,"type":21},"2030-06-15",{"name":122,"class":45},"Nationwide Children's Hospital",13,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100460636","phase-1-lutathera-for-treatment-of-recurrent-or-progressive-high-grade-cns-tumors-100460636","NCT05278208","Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors","Phase I\u002FII Study of Lutathera in Patients With Recurrent and\u002For Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET","All participants must meet the following inclusion and exclusion criteria. No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for \\[68Ga\\]Ga-DOTATATE PET) must be done within 7 days prior to enrollment.\n\n1. Screening Criteria\n\n   1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory. Note that patients with DIPG (based on radiographic\u002Fclinical diagnosis) who have undergone biopsy will be eligible with histologic diagnosis of grade II-IV infiltrating glioma. All tumors must have histologic verification either at the time of diagnosis or recurrence, except for patients meningioma who have not previously undergone biopsy or resection.\n\n   Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n\n   1.2 Prior Therapy Patients must have recurred\u002Fprogressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.\n\n   1.3 Screening Consent Participant\u002Flegal guardian is willing to sign a screening consent for \\[68Ga\\]Ga-DOTATATE PET imaging. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n2. Eligibility Criteria\n\n   * Phase I Age Patient must be ≥ 4 and \\\u003C12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.\n   * Phase II Age Patient must be 12 to \\\u003C\u002F=39 years at the time of enrollment.\n3. Inclusion Criteria\n\n   3.1 Uptake on \\[68Ga\\]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET\u002FCT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central radiology review).\n\n   3.2 Prior Therapy Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy, or any other treatment modality prior to entering this study.\n\n   3.3 Chemotherapy Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.\n\n   3.4 Investigational\u002FBiologic Agent\n\n   ●Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.\n\n   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\n   ●Monoclonal Antibodies and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.\n\n   3.5 Radiation\n\n   Patients must have had their last fraction of:\n   * Craniospinal irradiation or total body irradiation or radiation to \\> 50% of pelvis \\> 3 months prior to enrollment.\n   * Focal irradiation \\> 4 weeks prior to enrollment\n\n   3.6 Stem Cell Transplant\n\n   Patient must be:\n   * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease\n   * ≥ 3 months since autologous stem cell transplant prior to enrollment\n\n   3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or erythropoietin). Two weeks must have elapsed if patients received long-acting formulations.\n\n   3.8 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs (i.e., octreotide) for at least 24 hours.\n\n   3.9 Neurologic Status\n   * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.\n   * Patients with seizure disorders may be enrolled if seizures are well controlled.\n\n   3.10 Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 50. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\n   3.11 Organ Function\n\n   Patients must have adequate organ and marrow function, both for eligibility for enrollment, and to begin each subsequent cycle of Lutathera, as defined below:\n   * Adequate Bone Marrow Function as defined as:\n\n     * Absolute neutrophil count ≥ 1.0 x 109 cells\u002F L\n     * Platelets ≥100 x 109 cells\u002F L (unsupported, defined as no platelet transfusion within 7 days)\n     * Hemoglobin ≥8 g\u002Fdl (may receive transfusions)\n   * Adequate Renal Function as defined as:\n\n     * Creatinine clearance or radioisotope GFR \\>70mL\u002Fmin\u002F1.73m2 OR\n     * A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows:\n\n       1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL for males and females. 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL for males and females. 6 to \\\u003C 10 years: maximum serum creatinine 1.0 mg\u002FdL for males and females. 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n       ≥ 16 years: maximum serum creatinine 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n   * Adequate Liver Function as defined as:\n\n     * Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age\n     * AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional ULN\n     * Serum albumin ≥ 2g\u002FdL\n     * Coagulation parameters: INR \\\u003C1.5 times ULN and aPTT \\\u003C1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters\n   * Adequate Cardiac Function as defined as:\n\n     * Ejection fraction of ≥ 55% by echocardiogram\n     * Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)\n\n   3.12 Corticosteroids Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment, with a maximum dexamethasone dose of 2.5mg\u002Fm2\u002Fday.\n\n   3.13 Pregnancy Status Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   3.14 Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for at least 7 months after drug cessation in females of childbearing potential and for at least 4 months after drug cessation in males of child fathering potential.\n\n   3.15 Informed Consent The patient or parent\u002Fguardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.\n4. Exclusion Criteria\n\n   4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.\n\n   4.2 Presence of bulky disease Patients with bulky disease on imaging as described below are ineligible. Treating physicians are encouraged to request a rapid central imaging review to confirm fulfillment of these criteria if there are questions or concerns.\n\n   Bulky disease is defined as:\n   * Tumor with evidence of clinically significant uncal herniation or midline shift.\n   * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR.\n   * Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.\n\n   Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as long as no sites of disease meet above criteria for bulky disease.\n\n   4.3 Breast-feeding Nursing mothers are excluded from this study. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Lutathera.\n\n   4.4 Concurrent Illness\n   * Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.\n   * Patients 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 patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n   * Patients with type I diabetes.\n\n   4.5 Concomitant Medications\n   * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n   * Prior or current treatment with 177Lu-DOTATATE\u002FTOC or 90Y-DOTATATE\u002FTOC.\n\n   4.6 Prisoners will be excluded from this study.\n\n   4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or adhere to drug administration plan, other study procedures, and study restrictions.\n5. Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.",{"count":132,"type":21},65,[24,107],"This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \\\u003C12 years (Phase I) or 12 to \\\u003C\u002F=39 years (Phase II) to test its safety and efficacy, respectively.\n\nFunding Source - FDA OOPD (grant number FD-R-0532-01)",[110,136,137,85,138,139,140,27,141,142,143,28,144],"Meningioma","Embryonal Tumor","Anaplastic Ependymoma","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Malignant Glioma","Recurrent Primary Central Nervous System Neoplasm","Refractory Diffuse Intrinsic Pontine Glioma","Refractory Malignant Glioma","Refractory Primary Central Nervous System Neoplasm",[146,147,148],"Somatostatin Receptor","DOTATATE","Lutathera","2026-04-08",{"date":151,"type":39},"2026-04-13",{"date":153,"type":39},"2022-11-21",{"date":155,"type":21},"2033-11",{"name":122,"class":45},4,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":168,"briefSummary":169,"conditions":170,"keywords":178,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":70},"100599631","phase-1-gpc2-car-t-cell-therapy-for-relapsed-or-refractory-medulloblastoma-in-children-and-young-adults-100599631","NCT07087002","GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults","Phase I Clinical Trial of GPC2 Chimeric Antigen Receptor T (GPC2-CAR T) Cells for Relapsed or Refractory Medulloblastoma in Children and Young Adults","Inclusion Criteria:\n\n1. Diagnosis: Histologically confirmed diagnosis of medulloblastoma or other primary CNS embryonal tumor according to 2021 CNS WHO Classification (5th edition)\n\n   * Other acceptable CNS embryonal tumors include:\n   * Embryonal Tumor with Multilayered Rosettes (ETMR)\n   * Pineoblastoma\n   * Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS\n   * CNS neuroblastoma, FOXR2-activated\n   * CNS Embryonal Tumor NOS\n2. Recurrent\u002FRefractory Disease: History of relapsed and\u002For recurrent disease defined as tumor progression or recurrence following initial diagnosis and upfront treatment with curative intent, or failure to achieve disease control with standard curative-intent therapy.\n3. GPC2 Positive: H-score ≥ 100 by IHC staining performed on the (Prescreening Protocol IRB-78780, PI: Katherine Ryan, DO) at Stanford Clinical Anatomic Pathology Lab for GPC2 from a tumor sample any time since initial diagnosis.\n4. Evaluable Disease: Evaluable disease as per radiographic findings and\u002For positive cerebrospinal fluid cytology within 28 days of enrollment.\n5. Patients with VP shunts: Patients with pre-existing ventriculo-peritoneal (VP) shunt devices must have a programmable shunt device to enroll on this study. A VP shunt is not a requirement for this study.\n6. Prior therapy: No limit to the number of prior treatment regimens. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities).\n\n   At time of enrollment, subjects are on track to meet the required therapy wash out period(s) prior to apheresis.\n\n   a. At least 6 weeks following craniospinal radiation therapy. i. At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).\n\n   b. At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives.\n\n   c. At least 28 days following bevacizumab treatment. d. At least 30 days following any investigational drug. e. At least 12 weeks following systemic inhibitory or stimulatory immune checkpoint therapy.\n7. Age: ≥ 12 months to ≤ 30 years of age at time of enrollment The first 3 subjects treated with GPC2-CAR T cells must be ≥ 3 years old at time of infusion\n8. Performance Status: Subjects ≥ 16 years of age must have Karnofsky ≥ 60%. Subjects \\\u003C 16 years of age must have Lansky scale 60%; or ECOG performance status ≤ 2 (see Section 11.3).\n9. Normal Organ and Marrow Function \\[supportive care is allowed per institutional standards, i.e., filgrastim, transfusion\\]\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,000\u002FμL\n   3. Platelet count ≥ 75,000\u002FμL, with no platelet transfusion within 96 hours prior to enrollment\n   4. Absolute lymphocyte count (ALC) ≥ 150\u002FμL\n   5. PT\u002FINR, PTT ≤ 1.5 x ULN for age\n\n      Adequate renal, hepatic, cardiac, and pulmonary function defined as:\n   6. Serum creatinine \\\u003C 1.5 x ULN for age and gender, OR creatinine clearance or GFR (radioisotope or iothalamate) ≥ 70 mL\u002Fmin\u002F1.73 m2\n   7. Serum ALT or AST ≤ 3x ULN\n   8. Total bilirubin ≤ 1.5 mg\u002FdL, unless subject has Gilbert's Syndrome\n   9. Cardiac ejection fraction ≥ 45%\n   10. No evidence of physiologically significant pericardial effusion as determined by an ECHO\n   11. No clinically significant ECG findings\n   12. No clinically significant pleural effusion\n   13. Pulse oximetry ≥ 92% on room air, OR forced vital capacity ≥ 50% of predicted value\n10. Not Pregnant: Females of childbearing potential must have a negative pregnancy test.\n11. Contraception: 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 CAR T cells are detectable in peripheral blood.\n12. Must provide informed consent. All subjects ≥ 18 years of age must be able to give 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. Any patient with metastatic disease OUTSIDE the CNS.\n2. Unwilling or unable, in the investigator's judgement, to have a CSF reservoir (Ommaya or Rickham) placed. Does not apply to subjects who have a pre-existing device suitable for ICV delivery of CAR T cells and ICP monitoring.\n3. Clinical evidence of active\u002Fon-going significant increased intracranial pressure (i.e., impending herniation) or uncontrolled seizures.\n4. Prior receipt of a chimeric antigen receptor (CAR)-based therapy.\n5. Currently receiving anticoagulation therapy.\n6. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).\n\n   EXCEPTION: A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n7. Pregnancy or breastfeeding in a postpartum female.\n8. Known sensitivity or allergy to any agents\u002Freagents used in this study.\n9. History of prior other malignancy. EXCEPTION: Previously diagnosed and definitively treated more than 5 years prior to enrollment or whose prognosis is deemed good enough to not warrant surveillance.\n10. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n11. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n12. Significant medical diseases or poorly controlled conditions that, in the judgement of the investigator, put the subject at an unacceptable risk of complications, including but not limited to: uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, pulmonary fibrosis, clinically significant inflammatory disorders, immunodeficiency (e.g., HIV infection), immunocompromised for reasons other than malignancy (e.g., chronic corticosteroid therapy or other immunosuppressive therapy), renal failure including patients requiring dialysis, or clinically significant liver dysfunction.\n13. In the Investigator's judgment, the subject or parents\u002Fcaregivers (as required) will not be able to comply with the study procedures outlined in the study protocol including follow-up visits.","1 Year","30 Years",{"count":20,"type":21},[24],"This is a single-site, open-label Phase 1 clinical trial evaluating the feasibility, safety, and preliminary activity of autologous GPC2-targeted chimeric antigen receptor (CAR) T cells administered via intracerebroventricular (ICV) infusion in children and young adults with relapsed or refractory medulloblastoma or other eligible Central Nervous System (CNS) embryonal tumors.",[85,171,28,27,172,173,174,175,176,177],"Central Nervous System Embryonal Tumor","Pediatric Brain Tumor","Embryonal Tumor With Multilayered Rosettes (ETMR)","Pineoblastoma","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS","CNS Neuroblastoma","FOXR2-activated",[179,180,181,182,113,85,183,184,185,174,175,186,177],"GPC2-CAR T cells","Chimeric Antigen Receptor T cells","Intracerebroventricular CAR T","Pediatric CNS tumors","Refractory brain tumors","T cell therapy","Embryonal Tumor with Multilayered Rosettes (ETMR)","CNS neuroblastoma","2026-01-26",{"date":189,"type":39},"2026-01-27",{"date":191,"type":39},"2025-08-28",{"date":193,"type":21},"2027-08",{"name":195,"class":45},"Stanford University",{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":203,"sex":16,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":70},"100401013","phase-2-apatinib-combined-with-temozolomide-and-etoposide-capsules-in-the-treatment-of-recurrent-medulloblastoma-in-children-100401013","NCT04501718","Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children","A Single Arm Clinical Phase Ⅱ Study of Apatinib Combined with Temozolomide and Etoposide Capsules in the Treatment of Recurrent Medulloblastoma in Children","Inclusion Criteria:\n\n1. Age 2-21 (at the time of diagnosis), no gender limit.\n2. After biopsy or surgery, the first postoperative pathological diagnosis is medulloblastoma.\n3. The recurrence of the tumor is confirmed by MRI, that is, the diameter of the lesion on the enhanced MRI image is ≥1cm, and ≥2 slices (slice spacing 5mm) are visible; or after another biopsy or surgery, the pathological diagnosis is medulloblastoma.\n4. The time interval from the last radiotherapy is ≥4 weeks.\n5. The time interval from the last chemotherapy is ≥4 weeks, and the patients have fully recovered from the acute toxicity of the last treatment. If you receive nitrosourea chemotherapeutics before enrollment, the interval between enrollment and the last chemotherapy is ≥6 weeks.\n6. The interval between the last biopsy or surgery is ≥2 weeks.\n7. KPS score ≥50 (patient\\> 12 years old), or Lansky score ≥ 50 (patient ≤ 12 years old).\n8. If the patient is taking glucocorticoid therapy, the hormone dosage has stabilized or decreased for at least 1 week before the baseline MRI.\n9. The expected survival time is ≥12 weeks.\n10. The main organ functions are normal, and there is no serious blood, heart, lung, liver, kidney dysfunction and immune deficiency diseases. The laboratory inspection meets the following requirements:\n\n(1) Routine blood examination, which must be met (no blood transfusion within 14 days):\n\n1. HGB≥100g\u002FL;\n2. WBC≥3.0×109\u002FL; NEUT≥1.5×109\u002FL;\n3. PLT ≥100×109\u002FL; (2) The biochemical inspection shall meet the following standards:\n\na. BIL≤1.5 times the upper limit of normal (ULN); b. ALT and AST≤2.0×ULN; c. Serum Cr≤1.5×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); (3) Occult blood in stool (-); (4) Urine routine is normal, or urine protein \\\u003C(++), or 24-hour urine protein \\\u003C1.0 g; 11. The ECG shows that the heart rate is in the normal range (55-100 beats\u002Fmin), the QT interval is normal or slightly prolonged (QTc\\\u003C480ms), the T wave is normal or low, and the ST segment is normal or non-specific changes.\n\n12\\. The coagulation function is normal, without active bleeding and thrombosis.\n\n1. International standardized ratio INR≤1.5×ULN;\n2. Partial thromboplastin time APTT≤1.5×ULN;\n3. Prothrombin time PT≤1.5ULN. 13. Female patients of childbearing age must undergo a negative pregnancy test (serum or urine) within 7 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration; male patients of childbearing age should agree to During the observation period and within 8 weeks after the last administration, use appropriate methods of contraception.\n\n   14\\. Patients voluntarily provide 25-30 slices of tumor tissue after the last biopsy or surgery.\n\n   15\\. The patient has normal swallowing function and can swallow capsules. 16. The patient voluntarily joined the study and signed an informed consent form (ICF).\n\n   17\\. Those who are expected to have good compliance can follow up the efficacy and adverse reactions as required by the plan.\n\n   Exclusion Criteria:\n   1. Past application of anti-tumor angiogenesis drugs;\n   2. Those who are known to be allergic to any component of temozolomide, apatinib, and etoposide;\n   3. Are using antiepileptic drugs that induce liver drug enzymes, unless they have been replaced with antiepileptic drugs that are non-hepatic drug enzymes at least 2 weeks away from enrollment;\n   4. Patients with other malignant tumors, unless they have survived without progression for 5 years and the researcher believes that the risk of recurrence is low or patients with carcinoma in situ;\n   5. People with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure ≤140 mmHg \u002F diastolic blood pressure ≤ 90 mmHg);\n   6. Suffering from severe cardiovascular disease; T wave inverted or high tip of ECG, ST segment specific changes.\n   7. Urine routine test indicates urine protein ≥(++), or 24-hour urine protein ≥1.0g;\n   8. Abnormal coagulation function (INR\\>1.5 or prothrombin time (PT)\\>ULN+4 seconds or APTT\\>1.5×ULN), have bleeding tendency or are receiving thrombolytic or anticoagulant therapy;\n   9. There are many factors that affect the absorption of oral drugs, such as uncontrollable nausea and vomiting, chronic diarrhea and intestinal obstruction;\n   10. There is an infection that is difficult to control;\n   11. Have had significant clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, gastrointestinal perforation, fecal occult blood++ and above at baseline, intratumoral or Intracranial hemorrhage, or suffering from vasculitis, etc.;\n   12. Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n   13. Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n   14. Other situations that the researcher thinks are not suitable for inclusion.",true,"2 Years","21 Years",{"count":207,"type":21},44,[107],"This study is a prospective single-center clinical study, which aims to observe and evaluate the efficacy and safety of apatinib combined with temozolomide and oral etoposide in the treatment of recurrent medulloblastoma in children.",[27],"2024-10-09",{"date":213,"type":39},"2024-10-15",{"date":215,"type":39},"2020-10-28",{"date":217,"type":21},"2025-08-31",{"name":219,"class":45},"Beijing Sanbo Brain Hospital"]