A Phase II Study Assessing the Use of Omburtamab Radioimmunotherapy for Recurrent Medulloblastoma and Ependymoma in Children and Adolescents

Full Title

Phase 2 Study of Intraventricular Omburtamab-based Radioimmunotherapy for Pediatric Patients with Recurrent Medulloblastoma and Ependymoma (PBTC 058) (CIRB)

Purpose

In this study, researchers are evaluating the use of a radioimmunotherapy called ¹³¹I-omburtamab in children and adolescents with medulloblastoma and ependymoma (types of brain tumors) that have come back despite treatment. ¹³¹I-omburtamab binds to cancer cells in the body and releases radiation, which kills the cells. Early studies have also shown that ¹³¹I-omburtamab might strengthen the anticancer effects of chemotherapy.

Patients with medulloblastoma will receive intravenous (by vein) chemotherapy before and after ¹³¹I-omburtamab. Patients with ependymoma will only receive ¹³¹I-omburtamab. ¹³¹I-omburtamab is given directly into the brain through a catheter (thin tube) that is placed during surgery.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

• Patients with medulloblastoma must have cancer that came back or continued to grow despite prior therapy which did not include bevacizumab, irinotecan, and temozolomide (the chemotherapy used in this study).
• Patients with ependymoma must have cancer that came back or continued to grow despite prior therapy and have the B7H3 marker on their tumors.
• All patients must recover from the serious side effects of prior treatments before receiving the study therapy.
• Patients must be able to walk and do routine activities for more than half of their normal waking hours.
• This study is for patients under age 22.

For more information about this study and to inquire about eligibility, please contact 1-833-MSK-KIDS.