Evaluate the Response to 2 Induction Courses (12 Intravesical Instillations) of Bacillus Calmette-Guérin (BCG) for High Risk Superficial Bladder Cancer
Bladder Cancer - High Risk Superficial
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
Bacillus Calmette-Guérin (BCG), 14-174
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Bacillus Calmette-Guérin (BCG)
Type: Biological
Overall Status
This is a phase II study. This means that BCG therapy has already been found to be safe in humans. The investigators just want to see if using more treatments works better.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 or prostatic urethra (documented by radiological imaging or biopsy) within 12 months from the start of treatment.

- Patients who have not been treated with intravesical BCG therapy within the past 12 months prior to the current diagnosis.

Exclusion Criteria:

- Currently being treated or scheduled to have radiation treatment for bladder cancer during the study.

- Treatment with intravesical chemotherapy 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.

- Inability to hold the instillation for 1 hour.

- Presence of clinically significant infections or congenital or acquired immunodeficiency.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Harry W. Herr, MD - 646-422-4411
Start Date
October 2014
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page