Radioimmunotherapy for Recurrent Pediatric Brain Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
You may need to stop certain medications before joining the trial. Specifically, you cannot take enzyme-inducing antiepileptic drugs, certain herbal supplements, or medications that strongly affect liver enzymes (CYP3A4/5) within 7 days before enrollment. Check with the trial team for guidance on your specific medications.
What data supports the effectiveness of the drug combination used in the Radioimmunotherapy for Recurrent Pediatric Brain Cancer trial?
Is radioimmunotherapy for recurrent pediatric brain cancer safe?
Studies on bevacizumab (Avastin) and irinotecan (Camptosar, CPT-11) in children with brain tumors show that while these treatments can have moderate to severe side effects, such as high blood pressure and blood clots, they are generally within expected ranges. However, there is a risk of serious side effects, including rare cases of fatal toxicity.678910
What makes the drug combination of Bevacizumab, Irinotecan, Omburtamab I-131, and Temozolomide unique for treating recurrent pediatric brain cancer?
This drug combination is unique because it combines multiple agents that have shown potential in treating central nervous system tumors, with Bevacizumab targeting blood vessel growth in tumors and Temozolomide being able to cross the blood-brain barrier, which many drugs cannot do. This approach aims to enhance treatment effectiveness for recurrent pediatric brain cancer, where standard options are limited.23101112
What is the purpose of this trial?
A Phase 2 study investigating the addition of cRIT 131I-omburtamab to irinotecan, temozolomide, and bevacizumab for patients with recurrent medulloblastoma. A feasibility cohort is included to assess the feasibility of incorporating cRIT 131I-omburtamab for patients with recurrent ependymoma.Direct intraventricular delivery of radiolabeled tumor-specific antibodies may aid in both the detection and treatment of recurrent disease for these highly specific pediatric patients with recurrent tumors.
Research Team
Matthias Karajannis, MD, MS
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for patients under 22 years old with recurrent, progressive, or refractory medulloblastoma or ependymoma. They must have a performance score of ≥50%, be off growth factors for at least a week, and not have severe organ dysfunction. HIV/Hep B/C patients must be on effective therapy with undetectable viral load. Participants need confirmed tumor reactivity to B7H3 and should agree to use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy with irinotecan, temozolomide, and bevacizumab
Radioimmunotherapy
Participants receive 2 therapeutic doses of cRIT 131I-omburtamab
Maintenance Chemotherapy
Participants may resume maintenance chemotherapy with irinotecan, temozolomide, and bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bevacizumab
- Irinotecan
- Omburtamab I-131
- Temozolomide
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pediatric Brain Tumor Consortium
Lead Sponsor
Y-mAbs Therapeutics
Industry Sponsor
Y-mAbs Therapeutics, Inc
Collaborator
National Cancer Institute (NCI)
Collaborator
Memorial Sloan Kettering Cancer Center
Collaborator