30 Participants Needed

Fluoxetine + Chemotherapy for Brain Cancer

Recruiting at 2 trial locations
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Mustafa Khasraw, M.D. profile photo
Overseen ByMustafa Khasraw, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Duke University
Must be taking: Temozolomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Temozolomide is generally well tolerated and safe, with common side effects like fatigue, nausea, and mild blood-related issues. However, severe blood disorders like myelodysplastic syndrome and aplastic anemia have been reported, though they are rare.12345

What makes the combination of fluoxetine and temozolomide unique for treating brain cancer?

The combination of fluoxetine (an antidepressant) and temozolomide (a chemotherapy drug) is unique because fluoxetine enhances the effectiveness of temozolomide by activating a specific cell death pathway in glioma cells, potentially overcoming resistance to chemotherapy.26789

What data supports the effectiveness of the drug combination of Fluoxetine and Temozolomide for brain cancer?

Temozolomide (TMZ) is an effective drug for treating brain tumors like glioblastoma multiforme (GBM) and anaplastic astrocytoma, often used with radiotherapy to improve survival. It has a favorable safety profile and is being studied in combination with other treatments for various cancers.29101112

Who Is on the Research Team?

MK

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

I am using birth control and my pregnancy test was negative.
Able to undergo MRI brain with and without contrast
My brain tumor has come back after treatment.
See 7 more

Exclusion Criteria

Patients who are pregnant or breastfeeding
Patients with any history of mood/psychotic/substance use disorders
I am currently taking or have taken psychotropic medication in the last week.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fluoxetine and temozolomide pre-surgery to evaluate lysosomal stress and enhance temozolomide efficacy

4 weeks
Weekly visits for monitoring and drug administration

Surgery

Tumor resection or biopsy is performed to obtain samples for LAMP1 expression analysis

1 day
In-person surgical visit

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Fluoxetine
  • Temozolomide
Trial Overview The trial tests whether Fluoxetine causes stress in cell structures called lysosomes in the brain which might help Temozolomide work better against cancer cells. Participants will take Fluoxetine before their scheduled surgery where researchers will compare tissue samples from before and after starting the drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Fluoxetine pre-surgeryExperimental Treatment1 Intervention
Group II: Temozolomide pre-surgeryActive Control1 Intervention

Temozolomide is already approved in European Union, United States for the following indications:

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Approved in European Union as Temodal for:
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Approved in United States as Temodar for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Published Research Related to This Trial

In a phase II clinical trial involving 21 patients with newly diagnosed glioblastoma multiforme (GBM), the combination of temozolomide (TMZ) with radiotherapy resulted in a one-year survival rate of 58% and a median survival time of 15.7 months, indicating its efficacy in extending survival.
The treatment regimen was well-tolerated, with only mild to moderate non-hematological side effects and minimal severe hematological toxicity, suggesting that TMZ has a favorable safety profile compared to traditional chemotherapy agents.
Temozolomide in radio-chemotherapy combined treatment for newly-diagnosed glioblastoma multiforme: phase II clinical trial.Lanzetta, G., Campanella, C., Rozzi, A., et al.[2018]
Temozolomide is primarily used for treating refractory central nervous system cancers like anaplastic astrocytoma and glioblastoma, but ongoing clinical trials are exploring its efficacy and safety in newly diagnosed gliomas and other types of tumors.
Research is also investigating different dosing schedules and combinations with other treatments, suggesting that temozolomide could be a versatile option in cancer therapy beyond its current approved uses.
Future directions for temozolomide therapy.Yung, WK.[2019]
Temozolomide (TMZ) is shown to be more cost-effective than the traditional PCV treatment for glioblastoma multiforme (GBM), with costs of โ‚ฌ2367 per extra life-month and โ‚ฌ32,471 per quality-adjusted life-year (QALY).
The analysis indicates that TMZ has a high probability (over 60%) of being the most cost-effective treatment option at various willingness-to-pay thresholds, especially when considering quality of life improvements.
Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme.Martikainen, JA., Kivioja, A., Hallinen, T., et al.[2018]

Citations

Temozolomide in radio-chemotherapy combined treatment for newly-diagnosed glioblastoma multiforme: phase II clinical trial. [2018]
Future directions for temozolomide therapy. [2019]
Economic evaluation of temozolomide in the treatment of recurrent glioblastoma multiforme. [2018]
[Temozolomide: Temodal]. [2018]
Naringenin Sensitizes Resistant C6 Glioma Cells with a Repressive Impact on the Migrating Ability. [2022]
Temozolomide-related hematologic toxicity. [2018]
Temozolomide-induced aplastic anaemia: Case report and review of the literature. [2022]
Bioequivalence study of 20-mg and 100-mg temozolomide capsules (TOZ309 and Temodal&#174;) in glioma patients in China. [2021]
Phase II trial of temozolomide in patients with progressive low-grade glioma. [2022]
Fluoxetine synergizes with temozolomide to induce the CHOP-dependent endoplasmic reticulum stress-related apoptosis pathway in glioma cells. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Future directions in the treatment of malignant gliomas with temozolomide. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
A Case of Therapy-Related Acute Myeloid Leukemia Associated with Adjuvant Temozolomide Chemotherapy for Anaplastic Astrocytoma. [2018]
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