NCT00943839已完成不适用
Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease response
研究概览
简要总结
RATIONALE: Sunitinib malate 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.
PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.
详细描述
OBJECTIVES:
Primary
- To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.
Secondary
- To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
- To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 blood levels and overall survival of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SUVEGIL
Experimental
干预措施: sunitinib malate (Drug)
SUVEGIL
Experimental
干预措施: laboratory biomarker analysis (Other)
SUVEGIL
Experimental
干预措施: pharmacological study (Other)
结局指标
主要结局
Disease response
时间窗: 5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
时间窗: 5 years
次要结局
- Length of the response(up to 5 years)
- Disease-free survival(up to 5 years)
- Overall survival(up to 5 years)
研究者
研究点 (1)
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