Can a common antidepressant boost brain tumor treatment?

NCT ID NCT05634707

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-phase trial tests whether fluoxetine, an FDA-approved antidepressant, can increase stress in cell structures called lysosomes to make the chemotherapy drug temozolomide more effective against recurrent brain tumors. Ten participants with recurrent glioma will receive either fluoxetine plus temozolomide or temozolomide alone before surgery. Researchers will compare tumor samples to see if fluoxetine changes lysosome activity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fluoxetine and temozolomide
What this could lead to
If it works, this could point toward a way to make standard chemotherapy more effective for recurrent brain tumors.
What could go wrong
This is a very early, small trial with only 10 participants, so results may not apply broadly. The study focuses on cell changes, not direct patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

10 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

24 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 24 years of age Note: Fluoxetine has a warning about suicidal thoughts in children, adolescents, and young adults. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. 2. Patients with recurrent glioma 3. Tumor volume ≥ 1 cm3 4. Clinical indication for craniotomy for biopsy and resection of the lesion 5. Clinical indication for repeat treatment with Temozolomide 6. Karnofsky Performance Status (KPS) \> 70% 7. Adequate organ function: platelets \> 100,000/µL, hemoglobin \>9 gm/dL, ANC \> 1000/µL; creatinine \< 1.5x upper limit of normal (ULN), total bilirubin \< 1.5x ULN, AST/ALT \< 2.5x ULN within 72 hours prior to first administration of Fluoxetine 8. Able to undergo MRI brain with and without contrast 9. If the patient is a sexually active female of childbearing potential, whose partner is male, or if the patient is a sexually active male, whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test at the time of screening and within 48 hours of starting the infusion of the study drug. 10. Signed informed consent approved by the Institutional Review Board Exclusion Criteria: 1. Patients currently taking or who have taken any other anti-depressant medication within the past year 2. Patients currently taking psychotropic agents or who have taken other psychotropic agents within the past 7 days 3. Patients with any history of mood/psychotic/substance use disorders 4. Prior, unrelated malignancy requiring current active treatment except for cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin 5. Patients who are pregnant or breastfeeding 6. Patients with contrast-enhancing tumor crossing the midline, multifocal tumor, infratentorial tumor, tumor in eloquent brain regions, extensive tumor dissemination (subependymal or leptomeningeal), or in unsafe brain regions per the opinion of the treating neurosurgeon 7. Patients with worsening neurologic deficits, clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment 8. Unstable systemic disease in the opinion of the treating physician 9. Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation of recurrent tumor 10. Treated with immunotherapeutic agents within 4 weeks, alkylating agents within 4 weeks, nitrosoureas within 6 weeks, or non-alkylating chemotherapy within 2 weeks before enrollment, unless the patient has recovered from the expected toxic effects of such therapy 11. Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy 12. Patients who have developed disease progression while receiving temozolomide treatment are not eligible 13. Patients with allergy to fluoxetine 14. Patients with known cardiac disease, predisposing to long QT syndrome 15. Patients with diabetes mellitus, epilepsy, history of bleeding disorders, history of mania or susceptibility to angle-closure glaucoma 16. Patients with a history or who develop significant hyponatremia (serum sodium less than 130mmol/L) 17. Patients with a history of bipolar disorder or schizoaffective disorder 18. Patients with a history of seizure disorder prior to onset of their primary glioma 19. Patients who are currently taking or have taken in the past 2 months: Monoamine Oxidase Inhibitors (MAOI), Pimozide, Thioridazine, Drugs metabolized by the CYP2D6 pathway, Tricyclic Antidepressants, Antipsychotics, Serotonergic Drugs, Triptans, Tryptophan, Anticoagulant drugs (e.g., NSAIDs, aspirin, warfarin), Olanzapine 20. Patients who demonstrated thrombocytopenia following prior treatment with TMZ (platelets \< 50,000/µL)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

  • Stanford Cancer Institute

    Stanford, California, 94305, United States

  • The Preston Robert Tisch Brain Tumor Center at Duke University

    Durham, North Carolina, 27710, United States

  • UC San Diego Moores Cancer Center

    San Diego, California, 90074-1539, United States

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