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

Study Overview
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Brief Summary
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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.

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

Conditions
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Bladder Cancer, High Risk Superficial

Intervention / Treatment
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* Biological: Bacillus Calmette-Guérin (BCG)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bacillus Calmette-Guérin (BCG)<br>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. | Biological: Bacillus Calmette-Guérin (BCG)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | (by cystoscopy and cytology) Participants who have a response are those who have no evidence of disease in their bladder by both urine cytology and cystoscopy. Participants whose disease remains at the same stage or is downstaged without complete resolution are considered nonresponders and will be documented as having recurred. Participants with worsening tumor, defined as the upstaging from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Recurrence-free Survival After Complete Response | Progression is defined as the upstaging, from non-muscle invasive to muscle invasive disease, or metastatic disease will be documented as disease progression. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacillus Calmette-Guérin (BCG), 14-174