Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and recommend a phase II dose of volitinib (savolitinib) administered orally daily in children with refractory, progressive or recurrent primary CNS tumors. II. To define and describe the toxicities of savolitinib in children with refractory, progressive, or recurrent primary CNS tumors. III. To characterize the pharmacokinetics of savolitinib in children with refractory, progressive, or recurrent primary CNS tumors. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of savolitinib within the confines of a phase I study. II. To perform a genomic analysis within the confines of a phase I study to investigate correlation between response to treatment (as measured by objective response or progression free survival \[PFS\]) and the presence of specific genomic alterations (e.g., MET or HGF amplification, MET mutations, or MET fusion) and/or specific subgroups of disease. OUTLINE: This is a dose-escalation study of volitinib followed by a dose-expansion study. Patients receive volitinib orally (PO) once daily (QD). 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 magnetic resonance imaging (MRI) scans throughout study. After completion of study treatment, patients are followed up at 30 days, then periodically for up to 2 years.
Interventions
Primary Outcomes
Trial Information
NCT03598244
Active Not Recruiting
INTERVENTIONAL
PHASE1
National Cancer Institute (NCI)
December 15, 2025