M.D. Anderson Cancer Center
To learn if the study drug, ulixertinib, can cross over the blood-brain barrier in patients with recurrent brain tumors
Primary Objective: 1. Surgical: To evaluate the ability of ulixertinib to penetrate the BBB in patients with recurrent MAPK-activated gliomas (ulixertinib tumor concentration, tumor/plasma ratio) 2. Non-surgical: To assess anti-tumor activity of ulixertinib for patients with recurrent MAPK-activated gliomas (objective response rate (ORR)) Secondary Objectives: 1. To assess anti-tumor activity of ulixertinib for patients with recurrent MAPK-activated gliomas 1. Progression-free-survival (PFS) 2. Overall survival (OS) 3. Disease control rate (DCR) 4. Duration of response (DOR)…
Inclusion criteria: 1. Be willing and able to provide written informed consent for the trial (by participant or legally authorized representative), and assent when applicable. Participants with cognitive impairment will be enrolled. Cognitive function will be assessed by the treating physician or designee through a neurological examination. The formal consent for such participants will be obtained from their legally authorized representative. 2. Surgical: Be 18 years of age or older on day of signing informed consent. Non-surgical: Be 12 years of age or older on day of signing informed consen…
Surgical: Only adults with recurrent MAPK-activated gliomas will be accrued to the surgical cohort. Patients will receive Ulixertinib by mouth twice a day for two weeks and will undergo tumor resection subsequently on day 14 (+/- 3 working days).
Non-Surgical: Patients (12 years and above) with MAPK-activated gliomas will receive Ulixertinib by mouth twice a day continuously on a daily basis for cycles of 28 day.
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