The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.
Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.
Patients must not have received any prior anti-cancer chemotherapy.
Prior use of corticosteroids is allowed (see below
Peripheral absolute neutrophil count (ANC) ≥ 1000/μL
Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Total bilirubin ≤ 2 × institutional upper limit of normal
AST(aspartate aminotransferase)/ALT(alanine transaminase) ≤ 2.5 × institutional upper limit of normal 6.4 Adequate Pulmonary Function Defined as: Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).
Nationwide Children's Hospital
Lead sponsor
Pfizer
Collaborator