A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer
- Registration Number
- NCT02753309
- Brief Summary
This study is looking at the effects of Sirolimus (Rapamycin) on BCG-specific immunity during treatment of non-muscle invasive bladder cancer (NMIBC) with maintenance BCG.
- Detailed Description
This study will evaluate change from baseline in gamma-delta T cell numbers and function and Ag85 peptide-specific T cell responses following treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer
- In their treating physician's opinion is a good candidate for BCG therapy
- Be able to give informed consent
- Be age 18 or older
- Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
- Not have active, uncontrolled infections
- Not be on agents known to alter rapamycin metabolism significantly
- Not have a reported history of liver disease (e.g. cirrhosis)
- Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
- Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.
- Have muscle-invasive (≥T2) bladder cancer
- Unable to give informed consent
- Age < 18
- Immunosuppressed state (e.g. HIV, use of chronic steroids)
- Active, uncontrolled infections
- On agents known to alter rapamycin metabolism significantly
- Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
- Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
- Individuals with a reported history of liver disease (e.g. cirrhosis)
- Individuals who are not a good candidate for BCG in their treating physician's opinion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rapamycin 0.5mg Sirolimus Subject will take Rapamycin (Sirolimus) 0.5mg once daily for approximately 28 days Rapamycin 2.0mg Sirolimus Subject will take Rapamycin (Sirolimus) 2.0mg once daily for approximately 28 days
- Primary Outcome Measures
Name Time Method Percentage change in systemic (whole blood) gamma-delta T cells frequency 4 weeks and 3 months after therapy Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Percentage change in systemic (whole blood) gamma-delta T cell proliferation in response to BCG-specific antigens 4 weeks and 3 months after therapy Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
Percentage change in systemic (whole blood) Ag85 peptide-specific CD4 and CD8 T lymphocytes measured using human IFN-gamma release. 4 weeks and 3 months after therapy Change will be evaluated by comparing percentage increase or decrease following rapamycin or control (no therapy) against baseline measures
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States