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

Purpose of this Study

We are doing this study to find out if a drug called fluoxetine (the study drug) can cause changes to structures in your cells called lysosomes that then improve how well the chemotherapy drug temozolomide (TMZ) kills cancer cells in the brain. 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. The study drug is approved by the FDA to treat problems like depression and anxiety, but we do not know if it also might be beneficial in treating cancer.

Who Can Participate?

Eligibility

Adults ages 24+ who:
  • Are diagnosed with a type of brain cancer called malignant glioma that has returned or recurred
  • Are planning to have surgery for the recurrence
  • Are not currently taking (within the last 2 months) certain types of medications (for example, MAOIs, tricyclic antidepressants, or anticoagulants)
For more information about who can be in this study, please contact the study team at 919-684-5301.

Age Range

24-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The study is divided into two periods, a screening period and a study period. If you choose to join the study, you will go through a screening period to find out if you are eligible. During the screening period, you will:
  • Have physical and neurological exams
  • Have blood draws
  • Have a heart scan (ECG)
  • Have imaging done (MRI)
If you are eligible to take part in the study and wish to do so, you will get a random assignment (like a coin flip) to 1 of 2 groups:
  • One group will take fluoxetine by mouth once a day for 5 days at a lower dose that is then increased to a higher dose on Day 6 (maintenance dose), along with TMZ starting on Day 6 for 7 days followed by surgery for the recurrence.
  • The other group will take TMZ alone for 7 days followed by surgery for the recurrence.
At various visits during the study, you will have physical and neurological examinations, blood tests, ECGs, MRIs, and we will ask you to fill out questionnaires.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A surgical window of opportunity study to evaluate whether oral FLuoxetine can Induce cytotoxic lysosomal stRess and enhance Temozolomide efficacy in clinical glioma (FLIRT)

Principal Investigator

Mustafa
Khasraw

Protocol Number

PRO00110628

NCT ID

NCT05634707

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov