Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Psychotropic Drugs

Temozolomide

Fluoxetine

Antineoplastic Agents, Alkylating

Alkylating Agents

Selective Serotonin Reuptake Inhibitors

Serotonin

Neurotransmitter Agents

Antidepressive Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

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).

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.

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

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.

Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Stevie Threatt

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.

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.

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

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

Determine if fluoxetine increases lysosomal stress in patients with recurrent IDHwt glioma by evaluating LAMP1 expression in tumor samples obtained during surgery or biopsy

Estimate the objective radiographic response rate

Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to serum levels of fluoxetine.

Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to serum levels of norfluoxetine.

Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to intra-tumoral levels of fluoxetine.

Compare groups (Control Group, Fluoxetine Group (low-dose), Fluoxetine Group (high-dose)) with respect to intra-tumoral levels of norfluoxetine.

Duke University

Nutritional and Metabolic Diseases

Body Weight

Weight Loss

Wasting Syndrome

Cachexia

Body Weight Changes

Antiemetics

Central Nervous System Depressants

Gastrointestinal Agents

Olanzapine

Antipsychotic Agents

Olanzapine 2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.

2.5 mg by mouth (PO) Daily x 28 days, increasing about every 3-14 days in increments of 2.5-5 mg until the designated dose for that cohort is reached.

Aung Naing, MD

The goal of this clinical research study is to find the highest tolerable dose of the drug Olanzapine that can be given to patients with advanced cancer who are experiencing weight loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients who are experiencing it because of cancer. How this drug affects performance status, cancer-related symptoms, and nutritional status in patients with advanced cancer will also be studied.

Olanzapine is approved for the treatment of schizophrenia and bipolar disorder. However, patients who have received this drug for these reasons have also experienced weight gain. Further studies in patients with cancer showed an improvement in appetite, a decrease in nausea, and a control of flushing (feeling of warmth) and sweating.

If you are found to be eligible to take part in this study and before you receive your first dose of Olanzapine, you will have routine blood tests (about 2 teaspoons). You will be asked a series of questions about your nutrition and how well you are able to perform daily activities. These questions should take about 20 minutes to answer. Your answers will help the study doctor decide if the study drug is helping you gain weight and if your weight gain is helping you feel better. You will also have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Women who are able to have children must have a negative blood pregnancy test (about 1 teaspoon).

After the tests above are completed, you will begin receiving Olanzapine. The study drug will be taken by mouth once daily at bedtime for 28 days in a row. Seven different doses of the drug are planned with 6 patients enrolled on each level. The level you are assigned to will depend on when you are enrolled on this study. All participants will begin taking the same strength of the study drug. This will gradually increase about every 3 - 14 days until you reach the highest strength of the study drug for the dose level to which you are assigned.

About every 2 weeks during this study for the first month and then about once a month thereafter, you will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), and your medical history will be discussed. You will also have routine blood tests (about 2 teaspoons) to check your general health.

You will continue to receive the highest strength of the study drug for the dose level to which you are assigned for about 4 months unless you have intolerable side effects or if your weight continues to decrease. The study doctor will decide if you should continue receiving Olanzapine after 4 months.

This is an investigational study. The FDA has approved Olanzapine for mental health diseases (schizophrenia, acute mania, and bipolar disorder). Its use in preventing weight loss is experimental. Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

Olanzapine in Patients With Advanced Cancer and Weight Loss

Phase I Dose-Finding Pilot Study of the Safety and Tolerability of Olanzapine in Patients With Advanced Cancer and Weight Loss

M.D. Anderson Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Adenocarcinoma

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Immunomodulating Agents

Patients receive fluoxetine PO once QD for 10 days prior to surgery.

Jasmine Mitchell, MD

Randolph Hecht, MD

This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.

PRIMARY OBJECTIVE:

I. To evaluate alterations in tumor immune cell composition and activity under SSRI treatment.

OUTLINE:

Patients receive fluoxetine orally (PO) once daily (QD) for 10 days prior to surgery.

Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer

Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin

Will be assessed by changes in the immune cell composition in the tumor and its microenvironment before and after exposure to selective serotonin reuptake inhibitors therapy. Fixed tumor samples will be analyzed by immunohistochemistry for immune cell tumor infiltration and relevant lineage/activation/exhaustion markers. Will use descriptive statistics and graphical displays to compare the changes in tumor immune markers between the pre- and post-treatment tissue.

Jonsson Comprehensive Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Behaviors and Mental Disorders

Carcinoma, Non-Small-Cell Lung

Depression

Lung Neoplasms

Anxiety Disorders

Fatigue

Depressive Disorder

Adenocarcinoma of Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Behavioral Symptoms

Mental Disorders

Psychotic Disorders

Carcinoma, Bronchogenic

Bronchial Neoplasms

Quality of Life

Lung Adenocarcinoma

Gemcitabine

Cisplatin

Antimetabolites

Patients receive gemcitabine and cisplatin. Treatment repeats every 21 days for a total of six cycles. Patients receive fluoxetine for 7 weeks. Further use of fluoxetine is at the discretion of the patient and physician.

80 mg/m2 administered by intravenous (IV) over 30 minutes on Day 1 following the gemcitabine infusion. Treatment repeated every 21 days for a total of 6 cycles.

cisplatin

10 mg PO QD (by mouth once daily) starting on week 2 (day 8) and continuing for 7 weeks (days 8-57). After 7 weeks of fluoxetine treatment (day 57), further use of fluoxetine is at the discretion of the patient and physician.

fluoxetine

1000 mg/m2 intravenous (IV) administered by IV over 30 minutes on days 1 and 8. Repeat treatment every 21 days for a total of 6 cycles.

gemcitabine hydrochloride

Donna Greenberg, MD

This trial is designed to test the efficacy of fluoxetine to improve patient's quality of life during chemotherapy. An innovative application of a selective serotonin reuptake inhibitor may modulate the effects of fatigue, anxiety and depression which worsen quality of life.

OBJECTIVES:

Primary Objectives:

1. To preliminarily test the efficacy of fluoxetine to improve the quality of life of patients with advanced non-small cell lung cancer receiving chemotherapy by decreasing anxiety, depression and fatigue.
2. To test the feasibility of conducting a multi-center clinical trial of fluoxetine administered by oncologists concurrently with chemotherapy in patients with non-small cell lung cancer.

Secondary Objectives:

1. To describe the tumor response rate associated with the administration of gemcitabine/cisplatin in patients with advanced non-small cell lung cancer.
2. To describe the overall survival and failure-free survival associated with the administration of gemcitabine/cisplatin.
3. To describe the toxicity associated with the administration of gemcitabine/cisplatin.

Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

Fluoxetine in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC): A Phase II Pilot Study to Improve Quality of Life During Chemotherapy

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Immune System Diseases

Neoplasm Metastasis

Sclerosis

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Atrophy

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Neoplastic Processes

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Channel Blockers

Natriuretic Agents

Anticonvulsants

Neuroprotective Agents

Amiloride

Riluzole

Excitatory Amino Acid Antagonists

Protective Agents

Diuretics

Sodium Channel Blockers

Diuretics, Potassium Sparing

Amiloride 5 mg twice per day (5 mg once per day for first 4 weeks) for 96 weeks

Riluzole 50 mg twice per day (50 mg once per day for first 4 weeks) for 96 weeks

Fluoxetine 20 mg twice per day (20 mg once per day for first 4 weeks) for 96 weeks

Matched placebo 1 capsule twice per day (1 capsule a day for first 4 weeks) for 96 weeks

Placebo

Jeremy Chataway

Siddharthan Chandran

Multiple sclerosis (MS) is a disabling and progressive neurological disease that affects approximately 100,000 people in the UK. Many patients with MS experience two phases of disease; early MS (also called relapsing remitting MS, RRMS) and late MS (also called secondary progressive MS (SPMS). Early MS is due to inflammation of the nerves and the insulation (called myelin) that surrounds the nerves. Early MS is often characterised by periods of "attacks" interspersed with periods of "remission" with no or low disease symptoms. Late or progressive MS, which affects the majority of patients and typically emerges after 10-15 years of disease, results from actual nerve death (also called neurodegeneration). The progressive stage of disease results not in individual attacks but slow, cumulative and irreversible disability affecting walking, balance, vision, cognition, pain control, bladder and bowel function. Critically, and unlike early disease, there is no proven treatment for the late stage of MS. This is therefore an urgent and major unmet health need. MS-SMART directly addresses this need and will evaluate in this clinical trial three drugs (fluoxetine, riluzole or amiloride), all of which have shown some promise in MS, and in particular in SPMS. The trial is randomised and blinded. Randomisation means patients can get any one of the three active drugs or the inactive placebo/dummy; blinded means that neither patients nor the doctors will know which drug or placebo patients are receiving. Randomisation and blinding are standard approaches in clinical trials to ensure unbiased testing of drugs. All patients in MS-SMART will have periodic MRI (magnetic resonance imaging) brain scans and after 96 weeks these will be analysed. We will then compare the scans of each drug to the placebo or dummy to see if any of the drugs slow the rate of brain shrinkage that normally occurs in SPMS. This measured change in brain size is the primary (major) outcome of MS-SMART.

MS-SMART will test the efficacy and mechanism of action of three repurposed drugs (fluoxetine, riluzole and amiloride). All three drugs are in human use and have a good safety record. Critically for the purpose of MS-SMART they all have shown promise in early phase human MS clinical trials and target one or more of the pivotal neurodegenerative causing pathways implicated in SPMS. This is a Type B trial, as the IMPs are all in human use, have a good safety profile but are not currently used for this patient population.

The major need for patients with established and progressive MS is neuroprotective or disease modifying treatments that will slow or even stop disease progression. This study will evaluate three highly promising putative neuroprotective drugs as well as comprehensively address several of the current knowledge gaps related to the understanding of neuroprotection and neurodegeneration in SPMS through MRI and CSF examination.

MS-SMART is a multicentre, multi-arm, double blind, placebo-controlled phase IIb randomised controlled trial. A total of 440 patients with SPMS, with an entry criteria of an EDSS score of 4.0-6.5 will be equally randomised to receive placebo or one of the three active agents (fluoxetine 20mg bd, amiloride 5mg bd or riluzole 50mg bd). Patients will be followed up for 96 weeks with outcome-data collected after 0, 24, 48 and 96 weeks. That is, the duration of the trial for a trial participant is 96 weeks (a telephone assessment at week 100, 4 weeks post completion will be conducted). This is standard practice for phase II trials in SPMS.

MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial

A Multi-arm Phase IIB Randomised, Double Blind Placebo-controlled Clinical Trial Comparing the Efficacy of Three Neuroprotective Drugs in Secondary Progressive Multiple Sclerosis.

Persistent new T1 hypointense lesion count to assess neuroprotection in new lesions.

Grey matter volume change to assess cortical neuroprotection.

MR spectroscopy (MRS) to measure N-acetyl aspartate (reversal of neuronal mitochondrial dysfunction), myoinositol (prevention of glial cell inflammation) and glutamate (prevention of excitotoxicity).

Magnetic Transfer Ratio (MTR) to evaluate myelination.

Cervical cord imaging to assess cord neuroprotection.

Composite MRI/disability scores to increase sensitivity and study interaction of treatment mechanisms.

Quantification of Cerebrospinal fluid (CSF) neurofilament levels to measure neuroprotection.

Optical Coherence Tomography (OCT) measured Retinal Nerve Fibre Layer (RNFL) thickness as a measure of neuroprotection.

To establish whether a drug, from a panel of 3 leading candidate neuroprotective drugs, slows the rate of brain volume loss in SPMS over 96 weeks using MRI-derived percentage brain volume change (PBVC).

To establish that a multi-arm trial strategy is an efficient way of screening drugs in SPMS and can become the template for future work.

To explore any anti-inflammatory drug activity using the count of new and enlarging T2 lesions.

Examining for evidence of pseudo-atrophy (to ensure reliability of the primary outcome measure).

To examine the clinical effect of neuroprotection as measured by clinician - EDSS, MSFC, SDMT, SLCVA, relapse rate and patient reported outcome measures - MSIS29 v2, MSWS v2, Pain - NPRS and BPI and Fatigue - NFI.

To collect basic health economic data (EQ-5D) to inform future phase III trials.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Fluoxetine and Cytotoxic Lysosomal Stress in Glioma (FLIRT)	NCT05634707	Primary Brain T... Brain Tumor, Re...	Fluoxetine Temozolomide	24 Years -	Duke University
Olanzapine in Patients With Advanced Cancer and Weight Loss	NCT00489593	Advanced Cancer Weight Loss	Olanzapine	-	M.D. Anderson Cancer Center
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer	NCT06225011	Colorectal Aden...	Fluoxetine	18 Years -	Jonsson Comprehensive Cancer Center
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer	NCT06225011	Colorectal Aden...	Fluoxetine	18 Years -	Jonsson Comprehensive Cancer Center
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer	NCT00005850	Anxiety Disorde... Depression Fatigue Lung Cancer	cisplatin fluoxetine gemcitabine hyd...	-	Alliance for Clinical Trials in Oncology
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer	NCT00005850	Anxiety Disorde... Depression Fatigue Lung Cancer	cisplatin fluoxetine gemcitabine hyd...	-	Alliance for Clinical Trials in Oncology
Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer	NCT00005850	Anxiety Disorde... Depression Fatigue Lung Cancer	cisplatin fluoxetine gemcitabine hyd...	-	Alliance for Clinical Trials in Oncology
MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial	NCT01910259	Secondary Progr...	Amiloride Riluzole Fluoxetine Placebo	25 Years - 65 Years	University College, London

Spots Global Cancer Trial Database for fluoxetine

Every month we try and update this database with for fluoxetine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for fluoxetine

Every month we try and update this database with for fluoxetine cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for fluoxetine cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.