Fluoxetine + Chemotherapy for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing whether fluoxetine, a common antidepressant, can help improve the effectiveness of a chemotherapy drug called temozolomide (TMZ) in patients with recurrent brain cancer. The study focuses on patients whose cancer has returned and who are undergoing surgery. Fluoxetine is thought to make certain cell parts work harder, which helps TMZ kill cancer cells more effectively. Fluoxetine (Prozac) is one of the most frequently prescribed antidepressants in the United States and has been studied for its effects on depression in cancer patients.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants who are currently taking or have recently taken antidepressants, psychotropic agents, and several other specific drugs. It's important to discuss your current medications with the trial team to see if they are allowed.
Is the combination of Fluoxetine and Temozolomide safe for treating brain cancer?
What makes the combination of fluoxetine and temozolomide unique for treating brain cancer?
What data supports the effectiveness of the drug combination of Fluoxetine and Temozolomide for brain cancer?
Who Is on the Research Team?
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
Adults over 24 with recurrent glioma brain tumors suitable for surgery and repeat chemo with Temozolomide can join. They must be fairly active (KPS > 70%), have good organ function, and agree to use contraception if needed. Excluded are those on antidepressants within a year, other psychotropics recently, history of mood disorders, certain cancers, pregnant or breastfeeding women, specific tumor locations or conditions deemed unsafe by surgeons.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive fluoxetine and temozolomide pre-surgery to evaluate lysosomal stress and enhance temozolomide efficacy
Surgery
Tumor resection or biopsy is performed to obtain samples for LAMP1 expression analysis
Follow-up
Participants are monitored for safety and effectiveness after treatment and surgery
What Are the Treatments Tested in This Trial?
Interventions
- Fluoxetine
- Temozolomide
Temozolomide is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor