PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Study Evaluating the Safety and Tolerability of Percutaneous Vaccination Prior to Intravesical Instillation of Bacillus Calmette-Guerin (BCG) Mycobacteria for Non-Muscle Invasive Bladder Cancer

Conditions
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Bladder Cancer

Intervention / Treatment
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* Drug: Bacillus Calmette-Guerin (BCG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must: Be 18 years of age or older Be able to give informed consent Have newly diagnosed or recurrent multi-focal Ta, Large Ta, High Grade Ta, CIS or T1 Bladder Cancer Determined by treating urologist to be a good candidate for BCG Induction Therapy Have an adequate marrow function (defined as white blood cells greater than 1.5 x 103/µl (or 1,500 cells/mm3) and platelets greater than 150,000 cells/mm3; these results can be within last 60 days from the day of signing informed consent Exclusion Criteria: The patient cannot: Be less than18 years of age Unable to give informed consent Have a history of muscle invasive bladder cancer Be self-reported to be immune-compromised (HIV, chronic immunomodulators, chronic corticosteroids) Have a history of tuberculosis and/or received BCG Percutaneous Vaccination Pregnant or planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: non-muscle invasive bladder cancer<br>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. | Drug: Bacillus Calmette-Guerin (BCG)<br>* Intravesical instillation for non-muscle invasive bladder cancer<br>* Other names: Tice BCG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |