Primary Outcomes:

Primary Outcome 1 - Measure: Complete Response (CR) Rate

Primary Outcome 1 - Time Frame: 12 months

Primary Outcome 2 - Measure: Disease Free Survival (DFS)

Primary Outcome 2 - Time Frame: 24 months

Condition:

• Non-muscle Invasive Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria

1. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell
carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell
histology is predominant histology).
r/> 1. Cohort A: Histologically confirmed CIS (with or without Ta/T1 disease); Cohort B:
Histologically confirmed high-grade papillary disease (Ta/T1 only).

2. Patients are eligible if the diagnostic biopsy was done within 3 months of
treatment start and a cystoscopy demonstrating no resectable disease was done
within 6 weeks of treatment start (residual CIS is acceptable; patients with T1
disease must undergo repeat resection if muscularis propria is not present in
each biopsy sample). Patients with high-grade Ta and/or T1 disease should have
complete resection before study treatment.

3. Upper tract imaging within 6 months prior to study entry must not be suspicious
for upper tract malignancy.

2. Currently eligible for intravesical BCG therapy.

3. Age ≥ 18 years.

4. Performance status: ECOG performance status of 0, 1, or 2.

5. Laboratory tests performed within 21 days of treatment start:

1. Absolute neutrophil count (AGC/ANC) ≥ 1,000/µL

2. Platelets ≥ 100,000/µL [Patients may be transfused to meet this requirement]

3. Hemoglobin ≥ 8 g/dL [Patients may be transfused to meet this requirement]

4. Calculated glomerular filtration rate (GFR*) >40 mL/min or Serum creatinine ≤ 1.5
x ULN

5. Total bilirubin ≤ 2.0 X ULN

6. AST, ALT, ALP ≤ 3.0 X ULN

6. Adequate pulmonary function without any clinical sign of severe pulmonary dysfunction.
PFT > 50% FEV1 if clinically indicated by the investigator.

7. Negative serum pregnancy test if female and of childbearing potential
(non-childbearing is defined as greater than one year postmenopausal or surgically
sterilized).

8. Female participants of childbearing potential must adhere to using a medically
accepted method of birth control prior to screening and agree to continue its use
during the study or be surgically sterilized (e.g., hysterectomy or tubal ligation)
and males must agree to use barrier methods of birth control while on study.

9. Provide signed informed consent and HIPPA authorization and agree to comply with all
protocol-specified procedures and follow-up evaluations.

- using the following Cockcroft-Gault equation to calculate the eGFR for this
study: eGFR in mL/min = {(140-age in years) x (weight in kg) x F}/(serum
creatinine in mg/dL x 72) Where F =1 if male; and 0.85 if female

Exclusion Criteria

1. Prior BCG treatment or known hypersensitivity to BCG. Patients who have received more
than a single-dose post-operative treatment of mitomycin-C or gemcitabine are
excluded.

2. Concurrent use of other investigational agents.

3. History of or evidence of muscle-invasive, locally advanced, metastatic and/or
extravesical bladder cancer or any other cancer within the past 5 years, except:
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
adequately treated stage 1 or 2 cancer from which the patient is currently in complete
remission, or stable prostate cancer (under active surveillance or hormone control).

4. Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class
III or IV or other clinical signs of severe cardiac dysfunction.

5. Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to
study entry.

6. History or evidence of uncontrollable CNS disease.

7. Known HIV-positive.

8. Active systemic infection requiring parenteral antibiotic therapy. All prior
infections must have resolved following optimal therapy.

9. Concurrent febrile illness, active urinary tract infection, active tuberculosis, a
history of hypotension or anaphylactic reactions.

10. Ongoing chronic systemic steroid therapy required (>10 mg oral prednisone daily or
equivalent).

11. Women who are pregnant or nursing. Female patients of childbearing potential must have
a negative pregnancy test and must adhere to using a medically acceptable method of
birth control prior to screening and agree to continue its use during the study and
for 30 days after the last dose of study drug, or be surgically sterilized (e.g.,
hysterectomy or tubal ligation). Women of childbearing potential are defined as any
female who has experienced menarche and who is NOT permanently sterile or
postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses
without an alternative medical cause. Males must agree to use barrier methods of birth
control while on study and for 90 days post last dose of study drug.

12. Psychiatric illness/social situations that would limit compliance with study
requirements.

13. Other illness that in the opinion of the investigator would exclude the patient from
participating in this study.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No