A Study of Rapamycin Combined With Intravesical BCG in Patients With Non-muscle Invasive Bladder Cancer

This study will evaluate change from baseline in gamma-delta T cell numbers and function and
Ag85 peptide-specific T cell responses following treatment.

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