Selinexor, Temozolomide and Radiation Therapy for Newly Diagnosed Glioblastoma and Gliosarcoma

This clinical trial focuses on improving treatment for a type of brain tumor called glioblastoma and gliosarcoma. Currently, even with surgery, radiation, and a drug called temozolomide, the survival rate remains low due to the tumor's resistance to radiation. The study introduces a new drug, Selinexor, which has shown potential in making glioma cells more sensitive to radiation. The main goal is to evaluate the safety and the highest tolerable dose of Selinexor when used alongside temozolomide and radiation therapy in adults newly diagnosed with glioblastoma and gliosarcoma. The trial follows a '3 plus 3 design' with three dose escalation levels, enrolling three patients per dose level. Participants will undergo standard external beam radiation therapy and daily temozolomide. Selinexor will be administered concurrently. The primary outcome is to determine the maximum tolerated dose of Selinexor, defined as the dose where no more than one out of six participants experience severe side effects within a month of treatment completion. The study anticipates enrolling up to 24 patients over approximately two years.