Primary Brain TumorEarly Phase 1NCT05634707
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)
A Early Phase 1 study testing Fluoxetine and Temozolomide in people with Primary Brain Tumor and Brain Tumor, Recurrent, run by Duke University at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 years and older
- Conditions the study is for
- Primary Brain Tumor, Brain Tumor, Recurrent
- What is being tested?
- Fluoxetine and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 5 Aug 2023to 5 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients with recurrent glioma
- Tumor volume ≥ 1 cm3
- Clinical indication for craniotomy for biopsy and resection of the lesion
- Clinical indication for repeat treatment with Temozolomide
- Karnofsky Performance Status (KPS) > 70%
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- 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
- Able to undergo MRI brain with and without contrast
- 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.
- Signed informed consent approved by the Institutional Review Board
Who cannot join
- Patients currently taking or who have taken any other anti-depressant medication within the past year
- Patients currently taking psychotropic agents or who have taken other psychotropic agents within the past 7 days
- Patients with any history of mood/psychotic/substance use disorders
- 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
- Patients who are pregnant or breastfeeding
- 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
Show all 20Show fewer
- Patients with worsening neurologic deficits, clinically significant increased intracranial pressure (e.g., impending herniation), uncontrolled seizures, or requirement for immediate palliative treatment
- Unstable systemic disease in the opinion of the treating physician
- 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
- 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
- Treated with antiangiogenic agents (i.e., bevacizumab) within 4 weeks before biopsy
- Patients who have developed disease progression while receiving temozolomide treatment are not eligible
- Patients with allergy to fluoxetine
- Patients with known cardiac disease, predisposing to long QT syndrome
- Patients with diabetes mellitus, epilepsy, history of bleeding disorders, history of mania or susceptibility to angle-closure glaucoma
- Patients with a history or who develop significant hyponatremia (serum sodium less than 130mmol/L)
- Patients with a history of bipolar disorder or schizoaffective disorder
- Patients with a history of seizure disorder prior to onset of their primary glioma
- 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
- Patients who demonstrated thrombocytopenia following prior treatment with TMZ (platelets < 50,000/µL)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Preston Robert Tisch Brain Tumor Center at Duke University
Durham, North Carolina, 27710
NYU Langone Health
New York, New York, 10016
UC San Diego Moores Cancer Center
San Diego, California, 90074-1539
Stanford Cancer Institute
Stanford, California, 94305
About this study
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
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.
Read the detailed description
The purpose of this study is to determine whether oral fluoxetine can induce lysosomal stress and enhance Temozolomide (TMZ)-induced cell death in patients diagnosed with recurrent malignant glioma. The primary objective 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. Following consent, an optional biopsy may be performed to confirm recurrence of high-grade glioma. Recurrent glioma patients for whom retreatment with TMZ is appropriate and who are able to undergo tumor resection after 1 cycle of temozolomide will be enrolled in this study. Following enrollment, patients will randomly be assigned to (1:2) a study arm: control (n=10) or experimental (n=20). Within the experimental arm, two maintenance dose levels of fluoxetine are planned - 40mg OD (n=10) and 60mg OD (n=10). Patients randomized to the control arm will receive only 50 mg/m2 TMZ daily for 7 days (Days 6-12), followed by resection 21 days after initiation of the TMZ cycle. Patients randomized to the experimental arm will receive fluoxetine at 20 mg/day for 5 days (loading 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) This truncated initiation period of fluoxetine has been discussed with the psychiatry department at Duke University Hospital and has been judged to be safe given the additional monitoring precautions that are being included as part of this study. On Day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12). Resection will occur 21 days after initiation of the TMZ cycle on Day 27. Patients will remain on their assigned dose of fluoxetine through resection and follow-up, as long as the treatment regimen is tolerated. The change between baseline and post-resection will be computed to determine if co-administration of fluoxetine and TMZ will result in increased expression of LAMP1 on resected glioma cells. Within each group, a Wilcoxon signed-rank test will be conducted to determine if there are significant within group changes. A Kruskal-Wallis test will compare the three patient groups (Control Group, Fluoxetine Group [low-dose], Fluoxetine Group [high-dose]) with respect to these changes. If data suggests that parametric method are appropriate, then analysis of variance and a paired t-test will be conducted. Risks commonly associated with fluoxetine include nausea, diarrhea, lack of appetite, dry mouth, upset stomach or heartburn, constipation, insomnia, anxiety, nervousness, drowsiness, tremor, unusual dreams, headaches, dizziness, yawning, swelling of face, low body temperature, sexual dysfunction, rash, hives and itching, sweating, flu-like symptoms, sore throat, stuffy nose, and fever.
- Conditions
- Primary Brain Tumor, Brain Tumor, Recurrent
- Being tested
- Fluoxetine, Temozolomide
- Keywords
- Brain tumor, Fluoxetine, Prozac, Recurrent, Glioma, Temozolomide, Tumor resection, Tumor biopsy, Mustafa Khasraw, Pro00110628
- Medical subject headings
- Brain Neoplasms, Recurrence, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
Patients randomized to the experimental arm will receive fluoxetine 20mg/day for 5 days before escalation to a maintenance dose at day 6. On day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12)
- Arm 2A (n=10) - Escalate to maintenance 40mg/day fluoxetine on day 6
- Arm 2B (n=10) - This arm will be opened as long as there are less than 3/10 dose limiting toxicities in Arm 2A. Patients will escalate to maintenance 60mg/day fluoxetine on day 6
TemozolomideDrug
Patients randomized to the 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.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine pre-surgery | Experimental | 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). Receives: Drug: Fluoxetine |
| Temozolomide pre-surgery | Active comparator | 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. Receives: Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery
Determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained during surgery or biopsy
Measured: baseline, 1 month
Secondary outcomes (5)
Proportion of patients with partial or complete response at the time of surgical resection
Estimate the objective radiographic response rate
Measured: 1 month
Serum levels of fluoxetine using LC-MS/MS quantification
Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to serum levels of fluoxetine.
Measured: 1 month
Serum levels of norfluoxetine using LC-MS/MS quantification
Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to serum levels of norfluoxetine.
Measured: 1 month
Intra-tumoral levels of fluoxetine using LC-MS/MS quantification
Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to intra-tumoral levels of fluoxetine.
Measured: 1 month
Intra-tumoral levels of norfluoxetine using LC-MS/MS quantification
Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to intra-tumoral levels of norfluoxetine.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start5 Aug 2023
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mustafa Khasraw, MBChB, MD, FRCP, FRACP, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634707
- Sponsor's protocol ID
- Pro00110628
- Status last verified
- Sep 2025
- First submitted
- 22 Nov 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05634707
- Acronym / sponsor ID
- Pro00110628
- Conditions
- Primary Brain Tumor, Brain Tumor, Recurrent
- Keywords
- Brain tumor, Fluoxetine, Prozac, Recurrent, Glioma, Temozolomide, Tumor resection, Tumor biopsy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Jun 2027 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to determine whether oral fluoxetine can induce lysosomal stress and enhance Temozolomide (TMZ)-induced cell death in patients diagnosed with recurrent malignant glioma. The primary objective 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. Following consent, an optional biopsy may be performed to confirm recurrence of high-grade glioma. Recurrent glioma patients for whom retreatment with TMZ is appropriate and who are able to undergo tumor resection after 1 cycle of temozolomide will be enrolled in this study. Following enrollment, patients will randomly be assigned to (1:2) a study arm: control (n=10) or experimental (n=20). Within the experimental arm, two maintenance dose levels of fluoxetine are planned - 40mg OD (n=10) and 60mg OD (n=10). Patients randomized to the control arm will receive only 50 mg/m2 TMZ daily for 7 days (Days 6-12), followed by resection 21 days after initiation of the TMZ cycle. Patients randomized to the experimental arm will receive fluoxetine at 20 mg/day for 5 days (loading 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) This truncated initiation period of fluoxetine has been discussed with the psychiatry department at Duke University Hospital and has been judged to be safe given the additional monitoring precautions that are being included as part of this study. On Day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12). Resection will occur 21 days after initiation of the TMZ cycle on Day 27. Patients will remain on their assigned dose of fluoxetine through resection and follow-up, as long as the treatment regimen is tolerated. The change between baseline and post-resection will be computed to determine if co-administration of fluoxetine and TMZ will result in increased expression of LAMP1 on resected glioma cells. Within each group, a Wilcoxon signed-rank test will be conducted to determine if there are significant within group changes. A Kruskal-Wallis test will compare the three patient groups (Control Group, Fluoxetine Group [low-dose], Fluoxetine Group [high-dose]) with respect to these changes. If data suggests that parametric method are appropriate, then analysis of variance and a paired t-test will be conducted. Risks commonly associated with fluoxetine include nausea, diarrhea, lack of appetite, dry mouth, upset stomach or heartburn, constipation, insomnia, anxiety, nervousness, drowsiness, tremor, unusual dreams, headaches, dizziness, yawning, swelling of face, low body temperature, sexual dysfunction, rash, hives and itching, sweating, flu-like symptoms, sore throat, stuffy nose, and fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine pre-surgery | Experimental | Drug: FluoxetinePatients 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). |
| Temozolomide pre-surgery | Active comparator | Drug: TemozolomideTemozolomide 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. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Patients with recurrent glioma
- Tumor volume ≥ 1 cm3
- Clinical indication for craniotomy for biopsy and resection of the lesion
- Clinical indication for repeat treatment with Temozolomide
Key exclusion criteria (20 listed)
- Patients currently taking or who have taken any other anti-depressant medication within the past year
- Patients currently taking psychotropic agents or who have taken other psychotropic agents within the past 7 days
- Patients with any history of mood/psychotic/substance use disorders
- 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
- Patients who are pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluoxetinePatients randomized to the experimental arm will receive fluoxetine 20mg/day for 5 days before escalation to a maintenance dose at day 6. On day 6, patients will start treatment with 50 mg/m2 TMZ daily for 7 days (Days 6-12) * Arm 2A (n=10) - Escalate to maintenance 40mg/day fluoxetine on day 6 * Arm 2B (n=10) - This arm will be opened as long as there are less than 3/10 dose limiting toxicities in Arm 2A. Patients will escalate to maintenance 60mg/day fluoxetine on day 6 | Drug | Fluoxetine pre-surgery |
| TemozolomidePatients randomized to the 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. | Drug | Temozolomide pre-surgery |
Primary outcome
Change in LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery
Time frame: baseline, 1 month
Determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained during surgery or biopsy
5 secondary outcomes
Proportion of patients with partial or complete response at the time of surgical resection
Time frame: 1 month
Serum levels of fluoxetine using LC-MS/MS quantification
Time frame: 1 month
Serum levels of norfluoxetine using LC-MS/MS quantification
Time frame: 1 month
Intra-tumoral levels of fluoxetine using LC-MS/MS quantification
Time frame: 1 month
Intra-tumoral levels of norfluoxetine using LC-MS/MS quantification
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- The Preston Robert Tisch Brain Center at Duke UniversityLink provided by the sponsor.
- Duke HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Khasraw, MBChB, MD, FRCP, FRACP principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluoxetine and Temozolomide in people with Primary Brain Tumor and Brain Tumor, Recurrent, run by Duke University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LAMP1 expression in tumor samples obtained pre-resection via biopsy and during surgery (time frame: baseline, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.