An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer

Inclusion Criteria:

1. Have invasive (≥T1) bladder cancer

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

3. In their treating physician's opinion is a good candidate for radical cystectomy

4. In their treating physician's opinion does not need neoadjuvant chemotherapy prior to
cystectomy

5. Be able to give informed consent

6. Be age 18 or older

7. Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3
hemoglobin >9.5 gm/dl or platelets more than 100,000 cells/mm3).

8. Have adequate end-organ function (GFR >30, bilirubin <1.5, SGOT < 3x ULN)

9. Have a life expectancy > one year

10. Not have a prior history of non-bladder cancer unless the cancer is clinically stable
and not requiring active treatment

11. Not have received chemotherapy or radiotherapy in the prior 30 days

Exclusion Criteria:

1. Immunosuppressed state (e.g. HIV, use of chronic steroids)

2. Fixed disease (clinical T4)

3. Active, uncontrolled infections

4. Hepatic impairment (SGOT >3x ULN)

5. Unhealed wounds

6. 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.