Study on 131I-Omburtamab for Treating Recurrent Medulloblastoma and Ependymoma
Sponsor: Pediatric Brain Tumor Consortium
ClinicalTrials ID:NCT04743661
This clinical trial is exploring a new treatment approach using 131I-omburtamab combined with other cancer drugs for children and young adults with recurrent medulloblastoma or ependymoma. The study aims to see if this combination can help detect and treat these recurring brain tumors.
Patient Parameters
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Program Overview
The study is testing a new treatment that combines a radioactive drug, 131I-omburtamab, with chemotherapy drugs irinotecan, temozolomide, and bevacizumab. This treatment is for patients with recurring medulloblastoma or ependymoma, which are types of brain tumors. The treatment involves delivering the radioactive drug directly into the brain to help detect and treat the tumors. The study will also assess if this approach is feasible for patients with ependymoma.
Description
The study is divided into two parts:
Stratum 1 (Medulloblastoma):
- This part of the study focuses on patients with recurrent medulloblastoma. Patients will first undergo surgery if possible, followed by chemotherapy with irinotecan, temozolomide, and bevacizumab. If the disease is stable or improved after 2 or 4 courses of chemotherapy, patients will receive two doses of the radioactive drug 131I-omburtamab. After this, they may continue with maintenance chemotherapy for up to 12 courses or until the disease progresses.
Stratum 2 (Ependymoma):
- This part is a feasibility study for patients with recurrent ependymoma. Patients will undergo surgery if possible, and their tumors will be tested for a specific marker called B7H3. If positive, they will receive a small test dose of 131I-omburtamab to assess how the drug distributes in the body. If suitable, they will then receive two full doses of the radioactive drug.
The study aims to improve survival rates and assess the safety and effectiveness of this treatment combination for these specific brain tumors.
Eligibility Criteria
Inclusion Criteria
Stratum 1 (Medulloblastoma):
- Diagnosed with recurrent, progressive, or treatment-resistant medulloblastoma.
- Tumors must be confirmed by tissue sample or advanced imaging.
- Must have measurable disease on MRI or evidence of tumor cells in the cerebrospinal fluid (CSF).
- Under 22 years old.
- Must have a device to deliver the treatment directly into the brain.
- Must have had prior radiation therapy unless not suitable.
- Must have recovered from previous treatments and meet specific health criteria.
- Must agree to use birth control during and after the study.
Stratum 2 (Ependymoma):
- Diagnosed with recurrent, progressive, or treatment-resistant ependymoma.
- Tumors must be confirmed by tissue sample or advanced imaging.
- Must test positive for B7H3 marker.
- Under 22 years old.
- Must have a device to deliver the treatment directly into the brain.
- Must have had prior radiation therapy unless not suitable.
- Must have recovered from previous treatments and meet specific health criteria.
- Must agree to use birth control during and after the study.
Exclusion Criteria
Stratum 1 (Medulloblastoma):
- Pregnant or breastfeeding women.
- Previous treatment with the same combination of drugs.
- Serious wounds or fractures.
- History of certain abdominal or vascular conditions.
- Known bleeding disorders.
- Recent significant heart or vascular issues.
- Allergies to specific drug components.
- Taking certain medications that cannot be stopped.
Stratum 2 (Ependymoma):
- Pregnant or breastfeeding women.
- Serious unrelated illnesses that could affect treatment.
- Receiving other cancer treatments.
- Unable to comply with study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Cincinnati Children's Hospital Medical Center | 45229 | Cincinnati | Ohio |
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