PHASE 2 Study of Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors (GLOBOTRK)
St. Jude Children's Research Hospital
Summary
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.
Description
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…
Eligibility
- Age range
- Up to 3 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugEntrectinib
Given orally (PO) or enterally
- DrugCyclophosphamide
Given intravenous (IV)
- DrugEtoposide
Given IV
- DrugCarboplatin
Given IV
- BiologicalG-CSF
Given subcutaneous (SQ) or IV
- BiologicalPegfilgrastim
Given SQ as part of recommended Bridging Therapy instead of G-CSF.
- ProcedureSurgery
A gross total resection or significant debulking may become possible if a response to entrectinib is seen.
Locations (4)
- St. Jude Children's Research HospitalMemphis, Tennessee
- GRAACC Hospital (Grupo de Apoio ao Adolescente e à Criança com Câncer)São Paulo
- Hospital Santa MarcelinaSão Paulo
- King Hussein Cancer CenterAmman