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

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