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Alkylating Agent
Fluoxetine + Chemotherapy for Brain Cancer
Phase < 1
Recruiting
Led By Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial tests if Fluoxetine increases lysosomal stress (cell structure changes) to help chemotherapy (TMZ) kill brain cancer cells.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Fluoxetine may cause digestive issues, sleep disturbances, sexual dysfunction, anxiety or nervousness; it could also affect blood sugar levels or lead to eye problems like glaucoma. Temozolomide's side effects include nausea, fatigue, hair loss and increased risk of infections due to lowered white blood cell counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery
Secondary outcome measures
Intra-tumoral levels of fluoxetine using LC-MS/MS quantification
Intra-tumoral levels of norfluoxetine using LC-MS/MS quantification
Proportion of patients with partial or complete response at the time of surgical resection
+2 moreSide effects data
From 2012 Phase 4 trial • 43 Patients • NCT002456358%
Stomach Pains
8%
Weight Loss
4%
Nausea
4%
Trouble Sleeping
4%
Insomnia
4%
Nightmares
4%
Menstrual Cramps
4%
Silliness/Feeling too happy
4%
Emotional
4%
Suicidal Behavior
4%
Lit Paper on Fire
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fluoxetine pre-surgeryExperimental Treatment1 Intervention
Patients randomized to the experimental arm will receive fluoxetine at 20 mg/day for 5 days (initiation dose) followed by a maintenance dose of 40 mg/day starting on Day 6 (dose level 1) or 60 mg/day starting on Day 6 (dose level 2).
Group II: Temozolomide pre-surgeryActive Control1 Intervention
Temozolomide pre-surgery (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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine
2005
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,612 Total Patients Enrolled
Mustafa Khasraw, MBChB, MD, FRCP, FRACPPrincipal InvestigatorDuke University
6 Previous Clinical Trials
185 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using birth control and my pregnancy test was negative.My brain tumor has come back after treatment.My tumor is larger than 1 cm3.I am mostly independent and can care for myself.I am currently taking or have taken psychotropic medication in the last week.I have a specific medication history or condition.My tumor has specific characteristics or I have a neurological condition.I need surgery to remove a brain lesion.I have taken antidepressant medication in the last year.My blood counts and kidney and liver functions are within safe ranges.I am 24 years old or older.I am not currently receiving treatment for another type of cancer.I had low platelet counts after TMZ treatment.I need to be treated again with Temozolomide.
Research Study Groups:
This trial has the following groups:- Group 1: Fluoxetine pre-surgery
- Group 2: Temozolomide pre-surgery
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for enrolment in this research project?
"The information contained on clinicaltrials.gov reveals that this trial is no longer actively recruiting patients, as the last update was dated November 22nd 2022. Nevertheless, there are 2975 other trials in progress currently seeking participants."
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