A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
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
- Response Rate
研究概览
简要总结
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.
Secondary
- Determine duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
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
PEG-Intron, BM-CSF and thalidomide
干预措施: PEG-interferon alfa-2b (Biological)
PEG-Intron, BM-CSF and thalidomide
干预措施: GM-CSF (Biological)
PEG-Intron, BM-CSF and thalidomide
干预措施: thalidomide (Drug)
结局指标
主要结局
Response Rate
时间窗: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
次要结局
- Progression-free Survival(From registration until diease progression or death, whichever comes first.)
- Duration of Response(time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.)
- Frequency of Adverse Events Assessed by NCI CTC Version 2(From the first day of treatment until the end of treatment visit, an average of 6 months)