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Approximately 25 subjects will be enrolled and receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
Approximately 25 subjects will receive a standard WHO adult potency BCG immunization (1cc/50mg live mycobacilli) in the deltoid. Following a wait period after BCG vaccination, patients will then receive standard strength BCG intravesical therapy once a week for a total of 6 weeks. The BCG is instilled and held in the bladder for approximately 2 hours. While the BCG is retained in the bladder the patient should be repositioned every 30 minutes to maximize bladder surface exposure to the agent. Patients will undergo a cystoscopy every 3 months following most recent TURBT. Study duration last approximately 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-muscle invasive bladder cancer | Experimental | Every patient meeting eligibility criteria will receive a standard WHO adult potency Bacillus Calmette-Guerin (BCG) immunization (1cc/50mg live mycobacilli) in the right or left deltoid. Following a 19 - 31day wait period after BCG vaccination patients will then receive standard strength BCG intravesical therapy returning once a week for 6 consecutive weeks. Cystoscopy will be performed at 3 and 6 months. Interventions: BCG immunization in deltoid and BCG intravesical therapy once a week for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacillus Calmette-Guerin (BCG) | Drug | Intravesical instillation for non-muscle invasive bladder cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| BCG response | Percentage of patients with complete response at 3 months following therapy of combined percutaneous vaccination with TICE percutaneous Bacillus Calmette-Guerin (BCG) vaccine combined with standard protocol intravesical induction BCG vaccine for patients with non-muscle invasive transitional cell carcinoma of the bladder. | 3 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PPD conversion | PPD conversion from negative to positive (defined as ≥ 10 mm induration at 48-72 hours following PPD placement). | 3 months from BCG vaccination |
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Inclusion Criteria:
The patient must:
Exclusion Criteria:
The patient cannot:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Svatek, MD | Unv Texas Health Science Center San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D045424 |
| Complex Mixtures |