Primary Outcomes:

Primary Outcome 1 - Measure: Determine 1-year Recurrence Free Survival (RFS) rate

Primary Outcome 1 - Time Frame: 1 year

Primary Outcome 2 - Measure: Change in Urinary Quality of Life

Primary Outcome 2 - Time Frame: Scored at baseline and months 3, 6, 12 and 24. For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Primary Outcome 3 - Measure: Change in Cognitive Function

Primary Outcome 3 - Time Frame: EXIT will be scored at baseline and on months 12 and 24.For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Primary Outcome 4 - Measure: Change in Cognitive Function

Primary Outcome 4 - Time Frame: SLUMS will be scored at baseline and on months 12 and 24.For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Primary Outcome 5 - Measure: Change in Cognitive Function

Primary Outcome 5 - Time Frame: TAPS will be scored at baseline and on months 6, 12, and 24. For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Primary Outcome 6 - Measure: Change in cytoscopy consistent with recurrence (time to recurrence)

Primary Outcome 6 - Time Frame: Patients will undergo office-based cystoscopy with urine cytology every 3 months for the first 2 years, then every 6 months for 2 years, and at year 5, with biopsies per standard of care if necessary.

Primary Outcome 7 - Measure: Change in Short Physical Performance Battery

Primary Outcome 7 - Time Frame: SPPB will be scored at baseline and on months 6, 12, and 24. For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Primary Outcome 8 - Measure: Change in Handgrip Strength

Primary Outcome 8 - Time Frame: Handgrip Strength will be scored at baseline and on months 6, 12, and 24. For any subject who has a recurrence after enrollment, but prior to completing a full year of dosing at Visit 6, this will also be measured at the End of Treatment visit.

Condition:

• Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria:

- Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis, or
T1) 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 in complete
remission, or any other cancer from which the patient has been disease free for five
years.

- Patients with localized prostate cancer who are being followed by an active
survelillance program are also eligible.

- Patients must not be pregnant or nursing, as the use of Intravesical BCG is not
recommended during pregnancy. Women/ men of reproductive potential must have agreed to
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 12 consecutive months.
Examples of effective contraception include hormonal contraception, double barrier
method (condom with spermicidal cream, diaphragms with spermicidal cream, or condoms
with diaphragms), Intrauterine device, and/or 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 contraception method during
screening and agree to continue to use that contraception method through the end of
their participation in the study.

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

- Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis
demonstrating no evidence of nodal involvement or metastatic disease (MRI or CT scan)
within 90 days prior to registration. Patients with T1 disease must have re-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 squamous
cell carcinoma of the skin)

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

- Evidence of nodal involvement or metastatic disease (MRI or CT scan) within 90 days
prior to registration

- History of prior intravesical BCG

- History of prior Rapamycin treatment
Show More

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No