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Active, not recruiting Early Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05634707

Public ClinicalTrials.gov record NCT05634707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Surgical Window of Opportunity Study With Dose Escalation to Evaluate Whether Oral Fluoxetine Can Induce Cytotoxic Lysosomal Stress and Enhance Temozolomide Efficacy in Clinical Glioma

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this research study is to determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery. 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. Fluoxetine, a drug approved by the FDA to treat problems like depression and anxiety, can cause changes to structures in cells called lysosomes that then improve how well the chemotherapy drug temozolomide (TMZ) kills cancer cells in the brain.

Study identification

NCT ID
NCT05634707
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Early Phase 1
Lead sponsor
Duke University
Other
Enrollment
10 participants

Conditions and interventions

Eligibility (public fields only)

Age range
24 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 4, 2023
Primary completion
Dec 4, 2026
Completion
Jun 4, 2027
Last update posted
Sep 21, 2025

2023 – 2027

United States locations

U.S. sites
4
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
UC San Diego Moores Cancer Center San Diego California 90074-1539
Stanford Cancer Institute Stanford California 94305
NYU Langone Health New York New York 10016
The Preston Robert Tisch Brain Tumor Center at Duke University Durham North Carolina 27710

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05634707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 21, 2025 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05634707 live on ClinicalTrials.gov.

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