Repurposing Drugs as Immunotherapeutic Agents: Changes in Colorectal Tumor Immune Cells After Targeting Serotonin
Trial tests Prozac to boost immune response against early-stage colon cancer before surgery.
Plain English Summary
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer is a Phase 1 clinical trial sponsored by Jonsson Comprehensive Cancer Center studying Colorectal Adenocarcinoma. This trial is testing if the drug fluoxetine (Prozac) can change the immune cells within colon tumors before surgery. It is for patients with newly diagnosed colorectal cancer who do not require pre-surgery chemotherapy. Participants will take fluoxetine before their scheduled surgery. The alternative is standard surgical treatment without pre-operative fluoxetine. The trial aims to enroll 10 participants.
Official Summary
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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have been diagnosed with colorectal cancer that hasn't spread and doesn't need pre-surgery treatment. You cannot join if you have metastatic colon cancer, have had pre-surgery chemotherapy, or have specific heart rhythm issues or take certain medications. Your general health must be good enough to participate, with specific blood counts and organ function within certain limits. This trial is studying Colorectal Adenocarcinoma, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how fluoxetine affects the types and environment of immune cells within the tumor, aiming to make the tumor more vulnerable to the immune system. The specific primary outcome measures are: Immune cell composition and microenvironment (within a year of surgery). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial explores if a common antidepressant can be repurposed to help the body's immune system fight colon cancer, potentially filling a gap in treatments that enhance anti-cancer immunity before s This research targets Colorectal Adenocarcinoma, where improved treatment options are needed.
Investor Insight
This early-phase trial investigating a repurposed drug for a common cancer suggests potential for novel, cost-effective immunotherapies, though market impact is distant pending further trials. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if fluoxetine is right for you and what potential side effects you might experience. You will take fluoxetine daily before your surgery and have regular check-ups and blood tests. The study involves providing tumor samples before and after treatment, as well as blood samples. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- DRUG: Fluoxetine — Receive PO
Primary Outcomes
- Immune cell composition and microenvironment (within a year of surgery)
Full Eligibility Criteria
Inclusion Criteria: * Male or female ≥ 18 years of age at visit 1 * Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy * Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study * World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L * Platelets ≥ 100x10\^9/L * Hemoglobin ≥ 9 g/dL * Serum creatinine (sCr) ≤ 1.5 x upper limit of normal (ULN) * Creatinine clearance (Ccr) ≥ 40 mL/min (as calculated by Modified Cockcroft-Gault formula) * Serum total bilirubin ≤ 1.5 x ULN * Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN * Baseline corrected QT (QTc) within normal limits per the Bazett formula. Any electrocardiogram (EKG) done prior to consent is acceptable for baseline QTc monitoring. * Normal QTc ranges from 350-450 ms for adult men and from 360-460 ms for adult women Exclusion Criteria: * Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data * A diagnosis of metastatic colorectal adenocarcinoma * Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection * Individuals with absolute or relative contraindications to fluoxetine * Baseline prolonged QTc * Concurrently taking tamoxifen, pimozide, or thioridazine * Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy * Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)
Trial Locations
- UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Frequently Asked Questions
What is clinical trial NCT06225011?
NCT06225011 is a Phase 1 INTERVENTIONAL study titled "Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer." It is currently recruiting and is sponsored by Jonsson Comprehensive Cancer Center. The trial targets enrollment of 10 participants.
What conditions does NCT06225011 study?
This trial investigates treatments for Colorectal Adenocarcinoma. The primary condition under study is Colorectal Adenocarcinoma.
What treatments are being tested in NCT06225011?
The interventions being studied include: Fluoxetine (DRUG). Receive PO
What does Phase 1 mean for NCT06225011?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT06225011?
This trial is currently "Recruiting." It started on 2025-03-20. The estimated completion date is 2027-07-01.
Who is sponsoring NCT06225011?
NCT06225011 is sponsored by Jonsson Comprehensive Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06225011?
The trial aims to enroll 10 participants. The trial is currently recruiting and accepting new participants.
How is NCT06225011 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06225011?
The primary outcome measures are: Immune cell composition and microenvironment (within a year of surgery). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06225011 being conducted?
This trial is being conducted at 1 site, including Los Angeles, California (United States).
Where can I find official information about NCT06225011?
The official record for NCT06225011 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06225011. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06225011 testing in simple terms?
This trial is testing if the drug fluoxetine (Prozac) can change the immune cells within colon tumors before surgery. It is for patients with newly diagnosed colorectal cancer who do not require pre-surgery chemotherapy.
Why is this trial significant?
This trial explores if a common antidepressant can be repurposed to help the body's immune system fight colon cancer, potentially filling a gap in treatments that enhance anti-cancer immunity before s
What are the potential risks of participating in NCT06225011?
Common side effects of fluoxetine can include nausea, headache, insomnia, and fatigue. There is a risk of heart rhythm changes (QTc prolongation), especially if you have pre-existing heart conditions or take certain other medications. The study involves biopsies and surgery, which carry their own risks. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06225011?
Ask your doctor if fluoxetine is right for you and what potential side effects you might experience. You will take fluoxetine daily before your surgery and have regular check-ups and blood tests. The study involves providing tumor samples before and after treatment, as well as blood samples. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06225011 signal from an investment perspective?
This early-phase trial investigating a repurposed drug for a common cancer suggests potential for novel, cost-effective immunotherapies, though market impact is distant pending further trials. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take fluoxetine before their scheduled surgery. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Colorectal Adenocarcinoma Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.