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

NCT05634707 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-22

No results posted yet for this study

Summary

The purpose of this research study is to determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery. Lysosomes are organelles (structures in cells) that contain digestive enzymes (substances that break down chemicals) that help keep the cells free of extra or worn out cell parts. Fluoxetine, a drug approved by the FDA to treat problems like depression and anxiety, can cause changes to structures in cells called lysosomes that then improve how well the chemotherapy drug temozolomide (TMZ) kills cancer cells in the brain.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Mustafa Khasraw, MBChB, MD, FRCP, FRACP · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-05
Primary Completion
2026-12-05
Completion
2027-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05634707 on ClinicalTrials.gov