This phase I trial studies the side effects and best dose of trametinib and everolimus in treating pediatric and young adult patients with gliomas that have come back (recurrent). Trametinib acts by targeting a protein in cells called MEK and disrupting tumor growth. Everolimus is a drug that may block another pathway in tumor cells that can help tumors grow. Giving trametinib and everolimus may work better to treat low and high grade gliomas compared to trametinib or everolimus alone.
Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high grade glioma (HGG) (WHO grade III-VI)
Participants with LGG who have had surgery alone are not eligible.
Participants with neurofibromatosis type 1 (NF-1) are eligible but must have available tissue per study requirements neurofibromatosis (NF) status will be collected
Participants with spinal cord primaries or disseminated disease are eligible
Participants who are receiving any other investigational agent for treatment of their tumor
History of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus or trametinib
Participants without available tissue from prior surgery. (If clinical comprehensive testing has already been performed, the requirement for submission of tissue may be waived after discussion and review of results with study chairs)
Known strong inducers or inhibitors of CYP3A4/5, including enzyme inducing anti-convulsant drugs (EIACDs), grapefruit, grapefruit hybrids, pomelos, starfruit, and Seville oranges
University of California, San Francisco
Lead sponsor
Novartis Pharmaceuticals
Collaborator
Pediatric Brain Tumor Foundation
Collaborator
The Lilabean Foundation for Pediatric Brain Cancer Research
Collaborator