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.
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
Locations
Childrens Hospital Colorado
Principal Investigator
Kathleen Dorris
Study ID
Protocol Number: 21-4342
More information available at ClinicalTrials.gov: NCT04743661
Categories
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