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
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- BCG response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
non-muscle invasive bladder cancer
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.
干预措施: Bacillus Calmette-Guerin (BCG) (Drug)
结局指标
主要结局
BCG response
时间窗: 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.
次要结局
- PPD conversion(3 months from BCG vaccination)
研究者
Robert Svatek
Assistant Professor
The University of Texas Health Science Center at San Antonio