Savolitinib for Brain Tumors
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and best dose of volitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory). Volitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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 take certain medications that affect the liver enzyme CYP3A4 or herbal supplements like St. John's wort. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Savolitinib for brain tumors?
The research highlights the potential of targeted therapies like receptor tyrosine kinase inhibitors, which are similar to Savolitinib, in treating brain tumors by regulating growth factor signaling pathways. This suggests that Savolitinib, which targets similar pathways, might be effective for brain tumors.12345
How is the drug Savolitinib unique for treating brain tumors?
Savolitinib is unique because it specifically targets the MET receptor tyrosine kinase, which is often involved in the growth and spread of certain types of tumors, including brain tumors. This targeted approach may offer a new option for patients with brain tumors, especially when other treatments have not been effective.46789
Research Team
Ralph Salloum
Principal Investigator
Pediatric Brain Tumor Consortium
Eligibility Criteria
This trial is for young patients aged 5 to 21 with recurrent or stubborn primary CNS tumors, including medulloblastoma and gliomas. They must have tried standard treatments without success, be able to swallow tablets, and have stable neurological conditions. Pregnant women, nursing mothers, those with serious infections or other significant illnesses are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive volitinib orally once daily. Treatment repeats every 28 days for up to 39 courses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, X-ray imaging, and MRI scans throughout study.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days, then periodically for up to 2 years.
Treatment Details
Interventions
- Savolitinib
Savolitinib is already approved in China for the following indications:
- Non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor