Spots Global Cancer Trial Database for Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
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Trial Identification
Brief Title: Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
Official Title: A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS Tumors Harboring MET Aberrations
Study ID: NCT03598244
Study Description
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.
Keywords
Eligibility
Minimum Age: 6 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Saint Jude Children's Research Hospital, Memphis, Tennessee, United States
Texas Children's Hospital, Houston, Texas, United States
Hospital for Sick Children, Toronto, Ontario, Canada
Contact Details
Name: Ralph Salloum
Affiliation: Pediatric Brain Tumor Consortium
Role: PRINCIPAL_INVESTIGATOR
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