Clinical trial · Interventional
Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill any tumor cells remaining after surgery. PURPOSE: Phase II trial to study the effectiveness of combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients who have undergone surgery for medulloblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| iodine I 131 monoclonal antibody 3F8 | Radiation | — | UNRESOLVED |
| lomustine | Drug | Lomustine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- histologic proof of medulloblastoma
- description
- This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.
- interventionNames
- Drug: cisplatin
- Drug: lomustine
- Drug: vincristine sulfate
- Procedure: adjuvant therapy
- Radiation: iodine I 131 monoclonal antibody 3F8
- Radiation: radiation therapy
Primary outcomes (3)
- measure
- Feasibility
- timeFrame
- 2 years
- measure
- Progression-free Survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
Show eligibility criteria text
INCLUSION CRITERIA: * Patients must have histologic proof of medulloblastoma reviewed by the Department of Pathology at the Memorial Sloan-Kettering Cancer Center. * Patients must begin study prescribed therapy within 42 days of neurosurgical resection of the tumor * Age ≥ 3-years-old. Post-operative head MRI must confirm ≤ 1.5 cm2 of residual tumor is present. * Head and spine MRI and lumbar CSF cytology must not show any definitive evidence of leptomeningeal dissemination (Chang stage M-0). * Examinations evaluating extra-neural sites will not be mandated, but any performed for clinical indications must be free of metastatic disease. * No prior RT or chemotherapy for the medulloblastoma is permitted Patients must have adequate CSF flow (defined as lack of compartmentalization) on an 111-Indium DTPA flow study. * Patients must have adequate organ function as defined by: * Hepatic: total bilirubin \< 2.0 mg/dl, AST \< 3 x the upper limit of normal. * Renal: Calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m\^2. * The patient, or for minors, a parent or legal guardian, must give informed written consent indicating they are aware of the investigational nature of this study. EXCLUSION CRITERIA: * Unable to start study prescribed therapy within 42 days of neurosurgical resection of the tumor * Age less than 3 years \> 1.5 cm2 residual tumor on post-operative head MRI * Evidence of leptomeningeal dissemination on head or spine MRI or CSF cytology positivity * Evidence of extra-neural metastases * Prior radiation therapy or chemotherapy for the medulloblastoma * Inadequate CSF flow on 111-Indium DTPA flow study Patients with signs or symptoms suggestive of increased intracranial pressure (headache, emesis, ocular paresis) will not be eligible until they are cleared by neurology and/or neurosurgery. * Pregnancy * Total bilirubin ≥ 2.0 mg/dl * AST ≥ 3 x the upper limit of normal * Creatinine clearance and GFR \< 70 ml/min/1.73 m\^2
References
Publications (0)
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