Treatment with Dabrafenib and Trametinib for Adults with BRAF Mutated Papillary Craniopharyngioma to Reduce Tumor Size and Preserve Function

What this Trial Is About

Researchers are evaluating treatment for patients with papillary craniopharyngioma that has a BRAF mutation, a condition affecting the brain. This Phase II, open-label study explores using a combination of two oral drugs, dabrafenib and trametinib, to shrink tumors and possibly avoid or delay surgery, which can have serious side effects. About 25 patients will participate to assess tumor response and other health outcomes over time. Participants receive oral dabrafenib at 75 mg twice daily and trametinib at 2 mg once daily continuously until MRI scans show maximal tumor reduction or until treatment is stopped due to progression, side effects, or patient choice. The study includes patients newly diagnosed or with recurrent tumors not suitable for radical surgery. Treatment duration is at least one year, with ongoing evaluation by investigators. During the study, participants undergo regular MRI scans to measure tumor size and assessments of cognition, vision, hypothalamic function, and quality of life. Researchers will monitor progression-free survival and tumor response up to five years. Safety and tolerability are tracked, and quality of life assessments occur during and after treatment. The study aims to provide detailed information on how the drugs affect tumor control and patient well-being.

Treatment of BRAF ( B-Rapidly Accelerated Fibrosarcoma) Mutated Papillary Craniopharyngioma