Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Inclusion Criteria:

1. Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, orT1) bladder cancer within 90 days prior to enrollment

2. Be able to give informed consent

3. Be age 18 or older

4. Patients must not be taking oral glucocorticoids at the time of enrollment or haveactive, uncontrolled infections.

5. No other prior non-bladder malignancy is allowed except for the following:adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,adequately treated Stage I or II cancer from which the patient is currently incomplete remission, or any other cancer from which the patient has been disease freefor five years. Patients with localized prostate cancer who are being followed by anactive surveillance program are also eligible.

6. Patients with T1 disease must have cross-sectional imaging of abdomen/pelvisdemonstrating no evidence of nodal involvement or metastatic disease (MRI or CTscan) within 90 days prior to enrollment.

7. Patients with T1 disease must have re-resection confirming ≤ T1 disease within 90days prior to enrollment.

8. Patients must have had all grossly visible papillary tumors removed within 90 daysprior to enrollment or cystoscopy confirming no grossly visible papillary tumorswithin 90 days prior to enrollment.

9. Patients must not have received prior intravesical BCG.

10. Patients must not be pregnant or nursing as the use of Intravesical BCG is notrecommended during pregnancy. Women/men of reproductive potential must have agreedto use an effective contraceptive method while on study drug and for 12 weeks afterending treatment. A woman is considered to be of "reproductive potential" if she hashad menses at any time in the preceding 12 consecutive months. Examples of effectivecontraception are listed below:

11. Hormonal contraception

12. Double barrier method (condom with spermicidal cream, diaphragms withspermicidal cream or condoms with diaphragms)

13. Intrauterine device

14. Partner vasectomy

In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. Both male and female patients will be required to disclose an effective contraception method during screening and agree to continue to use that contraception method through the end of their participation in the study.

Exclusion Criteria:

1. Have muscle-invasive or higher (≥T2) bladder cancer

2. Unable to give informed consent

3. Under 18 years of age

4. Taking oral glucocorticoids at the time of enrollment.

5. Have active, uncontrolled infections

6. Presence of another cancer requiring active treatment (except basal cell carcinomaor squamous cell carcinoma of the skin)

7. Patients at risk of pregnancy that are unwilling or unable to take effectivecontraception during the study period or patients that are nursing during studyperiod. Women/men of reproductive potential must have agreed to use an effectivecontraceptive method or will be considered ineligible for study participation.

8. Evidence of nodal involvement or metastatic disease within 90 days prior toenrollment.

9. History of prior intravesical BCG

10. History of prior Rapamycin treatment

11. Taking strong inhibitors (such as ketoconazole, voriconazole, itraconazole,erythromycin, telithromycin, or clarithromycin) or inducers of CYP3A4 and/or P-gp (such as rifampin or rifabutin).