Phase II Study of Sunitinib Plus Extended Courses of Irradiated Allogeneic Lymphocytes for Patients With Renal Cell Carcinoma (SPECIAL Trial)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Infusing irradiated donor lymphocytes into the patient may help the patient's immune system kill tumor cells. Giving sunitinib together with irradiated donor lymphocytes may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sunitinib together with irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine progression-free survival of patients with metastatic clear cell renal cell carcinoma treated with sunitinib and irradiated allogeneic lymphocytes.
Secondary
- Determine rates and kinetics of clinical/radiographic response in these patients.
- Determine toxicities associated with treatment in these patients.
- Assess stable disease at 6 months in these patients.
- Assess overall survival of these patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sunitinib plus Irradiated Allogeneic Lymphocytes
干预措施: therapeutic allogeneic lymphocytes (Biological)
Sunitinib plus Irradiated Allogeneic Lymphocytes
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, on average up to 1 year.
Determined as the time from treatment with combination sunitinib with irradiated allogeneic lymphocytes to progressive disease or death whichever occurred first. Progression is determined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) as 20% increase in the sum of the of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Response Rate(Best responseFrom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.)
研究者
Roger Strair, MD, PhD
Professor of Medicine, RWJMS
Rutgers, The State University of New Jersey