Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors (NCT03598244) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
United States41 participantsStarted 2018-11-27
Plain-language 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.
Who can participate
Age range6 Years – 21 Years
SexALL
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Inclusion Criteria:
* Patients with a histologically confirmed diagnosis of a primary CNS tumor (medulloblastoma, high-grade glioma, or diffuse intrinsic pontine glioma \[DIPG\]) that is recurrent, refractory, or progressive. All tumors must have histologic verification at either the time of diagnosis or recurrence except patients with diffuse intrinsic brain stem tumors. These patients must have radiographic or clinical evidence of progression. Patients with a recurrent, progressive, or refractory primary CNS tumor with evidence of genetic activation of the MET pathway, regardless of histology, are also eligible to the Phase I component of this study
* Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI imaging that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment
* Efficacy Expansion Cohort: Patients must have a recurrent, progressive, or refractory primary CNS tumor with evidence of genetic activation of the MET pathway, regardless of histology. Specimens can be from diagnosis or recurrence and there is no time limit from when the specimen was obtained prior to enrollment onto the efficacy expansion cohort. Results from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory will be accepted for this eligibility criterion. Sites must provide a redacted copy of the local …