Stopped: Pending protocol amendment to transition to commercial drug supply
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Maximum tolerated dose (MTD) of trametinib in combination with everolimus for both continuous and intermittent dosing schedules
Timeframe: Up to 28 days
Incidence of adverse events for both continuous and intermittent dosing schedules
Timeframe: Up to 30 days after the last day of treatment
Dose limiting toxicities (DLTs) of the combination for both continuous and intermittent dosing schedules
Timeframe: Up to 28 days
Recommended phase 2 dose (RP2D)
Timeframe: Up to 28 days
Maximum Concentration (Cmax) of trametinib and everolimus
Timeframe: Up to 5 years
Area Under the Curve (AUC) of trametinib and everolimus
Timeframe: Up to 5 years