drugset / Trial / NCT05634707

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

NCT05634707

Phase 0 Active not recruiting 10 enrolled Duke University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-08-05
Primary completion
2026-12-05
Completion
2027-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoxetine Small molecule 40 mg Oral
Subject Fluoxetine Small molecule 60 mg Oral
Comparator Temozolomide Small molecule 50 mg/m2