Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients with Recurrent Medulloblastoma and Ependymoma
Stratum1 - This study is being done to see if we can lower the chance of the brain tumor growing or spreading by adding a new drug called 131I-omburtamab to the usual combination of chemotherapy drugs? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your recurrent medulloblastoma. The usual approach is defined as care most people get for recurrent medulloblastoma. Stratum 2 - This study is being done to answer the following question: Can a new drug called 131I-omburtamab be used safely in patients with recurrent ependymoma? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your recurrent ependymoma. The usual approach is defined as care most people get for recurrent ependymoma.
MoreChild to Adult
Stratum 1 - Patients must be < 22 years of age at the time of enrollment. Patients with a histologically confirmed diagnosis of medulloblastoma that is recurrent, progressive, or refractory to standard therapy. Stratum 2 - Patients must be < 22 years of age at the time of screening. Patients must have evidence of tumor reactivity for B7H3 (CD276) to be eligible for treatment. Patients with a histologically confirmed diagnosis of ependymoma that is recurrent, progressive, or refractory to standard therapy.
Please visit with your provider for the detailed eligibility
Treatment
Childrens Hospital Colorado
Kathleen Dorris, MD
Protocol Number: 21-4342
More information available at ClinicalTrials.gov: NCT04743661
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