Trial of Encapsulated Rapamycin (eRapa) for Bladder Cancer Prevention

Inclusion Criteria:

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

• Able to give informed consent

• 18 years or older

• Patients must not be taking oral glucocorticoids at the time of registration

• Not have active, uncontrolled infections

• 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 an activesurvelillance program are also eligible.

• 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. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12consecutive months. Examples of effective contraception include hormonalcontraception, double barrier method (condom with spermicidal cream, diaphragms withspermicidal cream, or condoms with diaphragms), Intrauterine device, and/or partnervasectomy. In addition to routine contraceptive methods, "effective contraception"also includes heterosexual celibacy and surgery intended to prevent pregnancy (orwith a side-effect of pregnancy prevention) defined as a hysterectomy, bilateraloophorectomy, or bilateral tubal ligation. However, if at any point a previouslycelibate patient chooses to become heterosexually active during the time period foruse of contraceptive measures outlined in the protocol, he/she is responsible forbeginning contraceptive measures. Both male and female patients will be required todisclose contraception method during screening and agree to continue to use thatcontraception method through the end of their participation in the study.

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

• 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 registration. Patients with T1 disease must havere-resection confirming ≤ T1 disease within 90 days prior to registration.

• Patients must no have received prior intravesical BCG

Exclusion Criteria:

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

• Unable to give informed consent

• Age 17 or younger

• Taking oral glucocorticoids at the time of registration

• Another cancer requiring active treatment (except basal cell carcinoma or squamouscell carcinoma of the skin)

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

• Evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 daysprior to registration

• History of prior intravesical BCG

• History of prior Rapamycin treatment