drugset / Trial / NCT05634707
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluoxetine | Small molecule | 40 mg | Oral |
| Subject | Fluoxetine | Small molecule | 60 mg | Oral |
| Comparator | Temozolomide | Small molecule | 50 mg/m2 | — |