Bladder Cancer
Conditions
Keywords
BCG, Rapamycin
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.
Interventions
DRUGSirolimus
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed