Selumetinib + Vinblastine for Low-Grade Glioma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have taken certain drugs like fluconazole or strong CYP3A4 inducers or inhibitors within 7 days before enrolling, and any multivitamin containing vitamin E must be stopped before enrollment.
What data supports the effectiveness of the drug Selumetinib for treating low-grade glioma?
Research shows that Selumetinib, a drug targeting the MAPK pathway, has shown promise in treating pediatric low-grade gliomas, with some patients responding well to the treatment. However, there are cases where resistance develops, indicating that while it can be effective, it may not work for everyone.12345
Is the combination of Selumetinib and Vinblastine safe for treating low-grade glioma?
Selumetinib has been studied in children with low-grade gliomas, and researchers have identified the recommended dose and potential side effects. While specific safety data for the combination with Vinblastine is not provided, Selumetinib alone has been evaluated for safety in pediatric patients.12346
What makes the drug Selumetinib unique for treating low-grade glioma?
Selumetinib is unique because it targets the MEK1/2 proteins in the MAPK pathway, which is often active in low-grade gliomas, offering a targeted approach compared to standard chemotherapy. This drug is particularly promising for patients with specific genetic mutations like BRAF, which are common in these tumors.12345
What is the purpose of this trial?
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
Research Team
Daniel C Bowers
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for children and young adults aged 2-21 (up to 25 in some phases) with low-grade glioma that's recurrent or progressive after treatment. Participants must have had prior therapy, a body surface area of at least 0.5 m^2, stable organ function, no severe allergies to the drugs being tested, controlled blood pressure, and the ability to swallow capsules.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive selumetinib and vinblastine for 17 cycles, followed by 10 additional cycles of selumetinib alone, or selumetinib alone for up to 27 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Selumetinib Sulfate
- Vinblastine Sulfate
Selumetinib Sulfate is already approved in United States, European Union for the following indications:
- Neurofibromatosis type 1
- Neurofibromatosis type 1
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor