Evaluating Local and Regional Immune Responses to Intravesical BCG Administration to Patients With Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Ability of BCG to Enhance Tumor Specific Immunity
研究概览
简要总结
Patients with invasive bladder cancer will be given 3-6 treatments (based on treatment response) BCG intravesically followed by a cystectomy.
详细描述
Patients with muscle invasive (≥T1) bladder cancer will be given 3-6 treatments (based on treatment response) intravesical TICE® BCG. BCG is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis.
After completion of BCG treatments the patient will undergo a cystectomy. A portion of bladder tumor tissue and lymph nodes will be collected for research purposes during the cystectomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have suspected or known invasive (≥T1) bladder cancer
- •Be able to give informed consent
- •Be age 18 or older
- •Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
排除标准
- •Have non-invasive (<T1) bladder cancer
- •Unable to give informed consent
- •< 18 or older
- •Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)
研究组 & 干预措施
BCG treatment of invasive bladder cancer
Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
干预措施: BCG strain of Mycobacterium bovis (Drug)
结局指标
主要结局
Ability of BCG to Enhance Tumor Specific Immunity
时间窗: At cystectomy at 3-6 weeks after BCG treatment
The tumor specific immunity is measured by the change in T cell proliferation post-treatment compared to the pre-treatment assessment, which will require a sample size of at least 10
次要结局
未报告次要终点