Phase II Open Label Trial of rIL-2 and Bevacizumab Combination in Patients With Metastatic Clear Cell Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Progression Free Survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop tumor cells from growing. Giving bevacizumab together with aldesleukin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with aldesleukin works in treating patients with metastatic clear cell carcinoma of the kidney.
详细描述
OBJECTIVES:
Primary
- To evaluate the effect of the combination of bevacizumab and aldesleukin on progression-free survival of patients with good- or intermediate-risk metastatic clear cell renal cell carcinoma.
Secondary
- To determine the objective response rate in patients receiving this regimen.
- To determine the time to progression in patients receiving this regimen.
- To evaluate immunomodulatory effects of this regimen in patients
- To evaluate the toxicity of this regimen in 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 120 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
Bevacizumab and Aldesleukin
干预措施: aldesleukin (Biological)
Bevacizumab and Aldesleukin
干预措施: bevacizumab (Biological)
结局指标
主要结局
Progression Free Survival
时间窗: From baseline (day -14) to disease progression (reported at 2 years)
Progression free survival is defined as the time between registration and progression of disease as defined by the RECIST criteria where there is a 20% increase in the diameter of the tumor and at least a 5mm absolute increase in diameter.
次要结局
- Objective Response Rate (Complete and Partial Response)(4 weeks after end of treatment)
- Percentage of Patients With Constitutional Adverse Events(From start of treatment to 30 days after treatment)
- Percentage of Patients With Neutropenia(From start of treatment to 30 days after treatment)
研究者
Jorge A. Garcia, MD
Principal Investigator
Case Comprehensive Cancer Center