Secondary Prevention Trial of Rapamycin in Patients With Resected Non-muscle Invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
研究概览
简要总结
The study is a multi-site Phase 3 double-blinded randomized placebo-controlled trial. Subjects are randomly assigned to receive either a placebo or oral Sirolimus: 0.5 mg daily. All subjects will be treated for 2 years or until disease recurrence. Patients will undergo endoscopic evaluation of the bladder every 3 months for the first 2 years following enrollment and then every 6 months for an additional 2 years on study. Selection of BCG immune therapy is at the discretion of the treating urologist but in general is reserved for high-risk patients. Patients concurrently receiving BCG immune therapy will receive standard BCG therapy including induction (weekly for 6 weeks) and maintenance (weekly for 3 weeks at 3 months, 6 months, and then every 6 months following tumor resection).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded for study staff (investigator) and patient
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
- •Pathologically (histologically) proven diagnosis of non-muscle invasive (Ta, Tis or T1) bladder cancer within 60 days prior to enrollment
- •Be able to give informed consent
- •Be age 18 or older
- •Not be in an immunosuppressed state (e.g. HIV, use of chronic steroids)
- •Not have active, uncontrolled infections
- •Not be on agents known to alter rapamycin metabolism significantly
- •Not have a reported history of liver disease (e.g. cirrhosis)
- •Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment except basal cell carcinoma or squamous cell carcinoma of the skin.
- •Not pregnant, or taking effective contraception before rapamycin therapy, during therapy and for 12 weeks after discontinuation of therapy.
排除标准
- •Have muscle-invasive (≥T2) bladder cancer
- •Unable to give informed consent
- •Age < 18
- •Immunosuppressed state (e.g. HIV, use of chronic steroids)
- •Active, uncontrolled infections
- •On agents known to alter rapamycin metabolism significantly
- •Another cancer requiring active treatment (except basal cell carcinoma or squamous cell carcinoma of the skin)
- •Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
- •Individuals with a reported history of liver disease (e.g. cirrhosis)
研究组 & 干预措施
Placebo Oral Tablet
Subject will be randomized to take the Placebo once daily for 2 years or until disease recurrence
干预措施: Placebo Oral Tablet (Drug)
Sirolimus (Rapamycin) 0.5 mg/day for 2 years
Subject will be randomized to take Sirolimus (Rapamycin) 0.5mg once daily for 2 years or until disease recurrence
干预措施: Rapamycin (Drug)
结局指标
主要结局
Test the hypothesis that rapamycin 0.5 mg daily increases recurrence-free survival for patients with non-muscle invasive bladder cancer
时间窗: Patients are treated for 2 years or until disease relapse
Recurrence is defined as histologically-proven bladder cancer (stage CIS, Ta, T1 or ≥T2)
次要结局
- To determine effects of rapamycin on recurrence-free survival (RFS) for subgroup of patients with non-muscle invasive bladder cancer concurrently receiving BCG immune therapy.(Patients are treated for 2 years or until disease relapse)
- To compare the effects of rapamycin on BCG-specific immunity during treatment of non-muscle invasive bladder cancer with maintenance BCG.(baseline and 6 months after registration)