PRIME: Pilot Study Evaluating Percutaneous Vaccination of BCG for Bladder Cancer
- Conditions
- Bladder Cancer
- Interventions
- Drug: Bacillus Calmette-Guerin (BCG)
- Registration Number
- NCT02326168
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description non-muscle invasive bladder cancer Bacillus Calmette-Guerin (BCG) 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.
- Primary Outcome Measures
Name Time Method BCG response 3 months after baseline 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.
- Secondary Outcome Measures
Name Time Method PPD conversion 3 months from BCG vaccination PPD conversion from negative to positive (defined as ≥ 10 mm induration at 48-72 hours following PPD placement).
Trial Locations
- Locations (1)
The University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States