Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 5, 2023

Primary Completion Date

December 5, 2026

Study Completion Date

June 5, 2027

Conditions
Primary Brain TumorBrain Tumor, Recurrent
Interventions
DRUG

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"

DRUG

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.

Trial Locations (4)

10016

NYU Langone Health, New York

27710

The Preston Robert Tisch Brain Tumor Center at Duke University, Durham

94305

Stanford Cancer Institute, Stanford

90074-1539

UC San Diego Moores Cancer Center, San Diego

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER

NCT05634707 - Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT) | Biotech Hunter | Biotech Hunter