11
Participants
Start Date
July 7, 2020
Primary Completion Date
September 29, 2023
Study Completion Date
July 30, 2026
Selinexor
Selinexor will be administered orally at an initial dose of 80 mg. The first dose will be given on day 2 of radiation and will thereafter be administered weekly on the second day of weekly radiation on weeks 1, 2, 4, and 5. If this dose level is tolerated, the dose will be escalated to 60 mg twice a week (days 1 and 4) on weeks 1,2,4,5. The third and final dose level will also be 60mg administered twice weekly for 6 weeks starting on days 1 and 4 radiation.
Temozolomide
Temozolomide will begin on the first day or evening prior of radiation and be administered orally daily at a dose of 75 mg/m\^2 during the radiation treatment. Temozolomide will continue until the completion of radiation and then will be stopped. Beginning 1-month post-radiation therapy (RT), the adjuvant temozolomide will be given per standard of care.
Generic Radiation therapy (RT)
Radiation therapy (RT) will be administered daily (Monday to Friday)
Selective serotonin receptor (5-HT3) antagonists
Anti-emetic for breakthrough nausea.
Olanzapine
2.5mg to 5mg once a day if weight loss is rapid.
Salt tablets
To treat hyponatremia, add salt tablets to participants diet per institutional guidelines.
Anti-diarrheal
Treat diarrhea with an anti-diarrheal per institutional guidelines
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH