10
Participants
Start Date
August 5, 2023
Primary Completion Date
December 5, 2026
Study Completion Date
June 5, 2027
Fluoxetine
"Patients randomized to the experimental arm will receive fluoxetine 20mg/day for 5 days before escalation to a maintenance dose at day 6. On day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12)~* Arm 2A (n=10) - Escalate to maintenance 40mg/day fluoxetine on day 6~* Arm 2B (n=10) - This arm will be opened as long as there are less than 3/10 dose limiting toxicities in Arm 2A. Patients will escalate to maintenance 60mg/day fluoxetine on day 6"
Temozolomide
Patients randomized to the control arm will receive 50 mg/m2 temozolomide daily for 7 days (Days 1-7), followed by resection or biopsy 21 days after initiation of the temozolomide cycle.
NYU Langone Health, New York
The Preston Robert Tisch Brain Tumor Center at Duke University, Durham
Stanford Cancer Institute, Stanford
UC San Diego Moores Cancer Center, San Diego
Lead Sponsor
Duke University
OTHER