Adoptive Cell Therapy for Bladder Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop using any immunosuppressive medications, like corticosteroids, at least 14 days before joining. However, certain types of corticosteroids, like inhaled or topical ones, are allowed. If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.
What data supports the effectiveness of the treatment Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) for bladder cancer?
Adoptive Cell Therapy using TIL has been successful in treating metastatic melanoma, showing a median overall survival of 52 months, and has potential for bladder cancer as TILs can be expanded from bladder tumors. Additionally, TIL therapy has shown promise in decreasing bladder tumor growth in animal studies.12345
Is adoptive cell therapy with tumor-infiltrating lymphocytes generally safe for humans?
Adoptive cell therapy using tumor-infiltrating lymphocytes has shown promise in treating cancers like melanoma, but it can have side effects mainly due to the chemotherapy and high-dose interleukin-2 used in the process. These side effects are usually reversible, though rare neurological effects have been reported.13678
How is adoptive cell therapy with TIL different from other bladder cancer treatments?
Adoptive cell therapy with tumor-infiltrating lymphocytes (TIL) is unique because it uses the patient's own immune cells, specifically T cells from their tumor, to fight cancer. This personalized approach aims to enhance the body's natural ability to target and destroy cancer cells, which is different from traditional treatments like chemotherapy or radiation that do not specifically target the immune system.12346
What is the purpose of this trial?
The purpose of the study is to evaluate the feasibility, safety and tolerability of intravesical adoptive cell therapy using TIL (tumor infiltrating lymphocytes) in participants with urothelial cell carcinoma (UCC) non-muscle invasive bladder cancer (NMIBC).
Research Team
Michael Poch, MD
Principal Investigator
Moffitt Cancer Center
Eligibility Criteria
This trial is for individuals who have been treated with BCG for high-grade non-muscle invasive bladder cancer (NMIBC) and show evidence of the disease. They must be in good health, understand the study, and consent to participate. Key eligibility includes a performance status of 0-1, adequate organ function, no recent intravesical chemotherapy or immunosuppressive drugs, no uncontrolled illnesses or certain infections like HIV or hepatitis B/C.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravesical adoptive cell therapy using TIL, administered four times over three weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall response rate
Treatment Details
Interventions
- Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL)
Adoptive Cell Therapy with Tumor-infiltrating Lymphocytes (TIL) is already approved in United States, European Union for the following indications:
- Melanoma
- Research trials for other cancers including bladder, breast, ovarian, renal cell, head-and-neck, non-small cell lung cancers, prostate cancer, sarcoma, and pancreatic carcinomas
- Melanoma
- Research trials for other cancers including bladder, breast, ovarian, renal cell, head-and-neck, non-small cell lung cancers, prostate cancer, sarcoma, and pancreatic carcinomas
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
United States Department of Defense
Collaborator