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).

               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.