Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients with Recurrent Medulloblastoma and Ependymoma

Primary Objective

Stratum 1- Recurrent Medulloblastoma: To estimate the event-free survival (EFS) of patients with relapsed medulloblastoma treated with irinotecan, temozolomide, bevacizumab, and compartmental radioimmunotherapy (cRIT) 131I-omburtamab. Stratum 2 – Recurrent Ependymoma: To assess feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma.

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Description

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.

Details
Age
Child to Adult
Eligibility
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
Locations

Childrens Hospital Colorado

Principal Investigator
Photograph of Kathleen Dorris

Kathleen Dorris

Study ID

Protocol Number: 21-4342

More information available at ClinicalTrials.gov: NCT04743661

Categories

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