Selumetinib vs. Chemotherapy for Brain Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on any investigational agents or receive any prior tumor-directed therapy like chemotherapy or radiation. It's best to discuss your current medications with the trial team to ensure they don't interfere with the study.
What data supports the effectiveness of the drug Selumetinib combined with Carboplatin and Vincristine Sulfate for brain cancer?
Carboplatin has shown some effectiveness in treating brain tumors, particularly when delivered directly to the brain to bypass the blood-brain barrier, as seen in studies with high-grade gliomas and brain metastases from non-small cell lung cancer. Additionally, carboplatin is often used as an alternative to cisplatin in chemotherapy regimens for other cancers, indicating its potential utility in brain cancer treatment.12345
What safety data exists for carboplatin and vincristine in treating brain cancer?
Carboplatin can cause low blood cell counts, leading to increased risk of infection and bleeding, and may also cause vomiting. Vincristine can cause nerve damage, leading to numbness or tingling in the hands and feet. Hypersensitivity reactions to carboplatin are a concern, and some patients may experience severe allergic reactions.12678
How does the drug Selumetinib differ from other treatments for brain cancer?
Selumetinib is unique because it targets specific pathways involved in cancer cell growth, unlike traditional chemotherapy which attacks rapidly dividing cells in general. This targeted approach may offer a different side effect profile and effectiveness, especially in cases where standard chemotherapy has limited success.1291011
What is the purpose of this trial?
This trial is comparing a new drug, selumetinib, with standard chemotherapy to treat patients with a specific type of brain tumor. The patients do not have a certain genetic mutation and are not affected by a genetic disorder. Selumetinib works by blocking enzymes needed for tumor growth, while the standard drugs kill or stop tumor cells from dividing.
Research Team
Peter M de Blank
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for children and young adults aged 2 to 21 with low-grade glioma brain tumors without certain genetic mutations or neurofibromatosis. They should not have had previous tumor treatments except surgery, must be able to swallow capsules, and meet specific health criteria like normal organ function tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive vincristine sulfate and carboplatin intravenously, with blood collection and MRI at baseline and end of induction
Maintenance
Patients continue receiving vincristine sulfate and carboplatin intravenously, with blood collection and MRI throughout the trial
Treatment with Selumetinib
Patients receive selumetinib sulfate orally twice daily, with blood collection and MRI throughout the trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin; Vincristine Sulfate
- Selumetinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor