About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Previous exposure to cytotoxic chemotherapy or radiotherapy
Patients must be <3 years of age at the time of diagnosis (date of surgical resection/biopsy)
High-grade glioma (World Health Organization [WHO] grade III or IV) harboring NTRK1/2/3 or ROS1 gene fusions as determined by central pathology review
Patients must have measurable disease as defined by RAPNO criteria
Trial design
Treatments tested in this trial
- Entrectinib
- Cyclophosphamide
- Etoposide
- Carboplatin
- G-CSF
- Pegfilgrastim
- Surgery
Treatment groups
Sponsors and collaborators
St. Jude Children's Research Hospital
Lead sponsor
Hoffmann-La Roche
Collaborator