S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer

Inclusion Criteria:

   - Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage
   urothelial cell carcinoma of the bladder within 90 days of registration

   - Patients must have had all grossly visible papillary tumors removed within 30 days
   prior to registration or cystoscopy confirming no grossly visible papillary tumors
   within 30 days prior to registration

   - Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis
   demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or
   computed tomography [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 have high-grade bladder cancer as defined by 2004 World Health
   Organization (WHO)/International Society of Urological Pathology (ISUP) classification

   - Patients must not have pure squamous cell carcinoma or adenocarcinoma

   - Patients' disease must not have micropapillary components

   - Patients must have no evidence of upper tract (renal pelvis or ureters) cancer
   confirmed by one of the following tests performed within 90 days prior to
   registration: CT urogram, intravenous pyelogram, magnetic resonance (MR) urogram, or
   retrograde pyelograms

   - Patients must not have nodal involvement or metastatic disease

   - No other prior 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 surveillance
   program are also eligible

   - Patients must have a Zubrod performance status of 0-2

   - Patients must not have received prior intravesical BCG

   - Patients must not have known history of tuberculosis

   - Patients must be PPD negative within 90 days prior to registration; PPD negativity is
   defined as < 10 mm diameter induration (palpable, raised hardened area) in the volar
   forearm at 48-72 hours following injection with standard tuberculin dose (5 units, 0.1
   ml)

   - Patients must be >= 18 years of age

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

   - Patients must not be planning to receive concomitant biologic therapy, hormonal
   therapy, chemotherapy, surgery, or other cancer therapy while on study

   - Prestudy history and physical must be obtained within 90days prior to registration

   - Patients must not be pregnant or nursing; 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; 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

   - Patients must be offered the opportunity to participate in specimen banking for future
   studies to include translational medicine studies