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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer; High Risk Superficial

Treatments: Biological: Bacillus Calmette-Guérin (BCG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02281383

14-174

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Bacillus Calmette-Guérin (BCG)

Experimental group

Description:

Patients will be treated with an induction course (6 intravesical instillations) of BCG followed by a second induction course (6 intravesical instillations), with a recovery period between the 2 treatment courses.

Treatment:

Biological: Bacillus Calmette-Guérin (BCG)