Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer

Lead Sponsor

Memorial Sloan Kettering Cancer Center

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Patients must have high risk non-muscle invasive urothelial bladder carcinoma (Tis, TaHG, or T1) that is pathologically confirmed by the Memorial Sloan Kettering Department of Pathology or a documented history of TaHG or T1 non-muscle invasive urothelial bladder tumors.
•18 years and older
•All visible papillary lesions must be macroscopically resected within 60 days of treatment initiation.
•Absence of urothelial carcinoma involving the upper urinary tract (documented by radiological imaging or biopsy) preferably within 12 months from the start of treatment. Should the imaging or biopsy be performed outside this window it will be up to the physicians discretion to re-scan/biopsy.
•Patients who have received a single dose of mitomycin C following staging TUR.

•Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.
•Treatment with intravesical BCG or chemotherapy for a patient's current \<T2 tumor during the 12 months prior to the current diagnosis.
•Currently being treated or scheduled to have treatment with any systemic or intravesical chemotherapeutic agent during the study.
•Currently being treated with or having been treated in the last 12 months with any investigational drug for high risk superficial bladder cancer.
•Previous muscle-invasive (i.e., stage T2 or higher) transitional cell carcinoma of the bladder.
•Currently being treated for metastatic transitional cell carcinoma.
•Scheduled to have surgery for bladder cancer during the study.
•Presence of clinically significant infections or congenital or acquired immunodeficiency.

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