St. Jude Children's Research Hospital
This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.
PRIMARY OBJECTIVE * To determine the overall response rate of entrectinib when used as first line therapy in patients who are younger than 3 years of age with NTRK1/2/3- or ROS1-fused high-grade glioma (HGG) (Cohort 1). SECONDARY OBJECTIVES * To estimate the 2-year and 5-year progression free survival (PFS) and overall survival (OS) in patients who are younger than 3 years of age with NTRK1/2/3- or ROS1-fused HGG treated with entrectinib as first line therapy (Cohort 1). * To estimate the duration of response (DOR) in patients who are younger than 3 years of age with NTRK1/2/3- or ROS1-fuse…
Inclusion Criteria: Screening Phase * Age from birth to age \<3 years at the time of diagnosis (date of surgical resection/biopsy) * Participant with presumed newly diagnosed tumor in the supratentorial compartment * Patient must have measurable disease based on RAPNO criteria * ≤84 days since surgery (resection or biopsy) * Available tumor tissue for central review * Parent/guardian has the ability to understand and the willingness to sign a written informed consent document according to institutional guidelines Exclusion Criteria: Screening Phase * Previous exposure to cytotoxic chemother…
Given orally (PO) or enterally
Given intravenous (IV)
Given IV
Given IV
Given subcutaneous (SQ) or IV
Given SQ as part of recommended Bridging Therapy instead of G-CSF.
A gross total resection or significant debulking may become possible if a response to entrectinib is seen.