NCT00492440终止1 期
A Phase I Study of Subcutaneous "CYT 107" (Interleukin-7) in Refractory Metastatic Melanoma or Renal Cell Carcinoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Cytheris SA
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Safety of recombinant interleukin-7 (IL-7)
研究概览
简要总结
RATIONALE: Interleukin-7 may stimulate the white blood cells to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 in treating patients with metastatic melanoma or locally advanced or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the safety of recombinant interleukin-7 (IL-7) in patients with metastatic melanoma or locally advanced or metastatic renal cell carcinoma.
- Confirm the previously documented safety profile of non-glycosylated IL-7 in these patients.
- Determine the safety of higher doses of recombinant IL-7 in these patients.
- Determine the maximum tolerated dose of recombinant IL-7 in these patients.
- Determine the biologically active dose of recombinant IL-7 in these patients.
Secondary
- Determine the pharmacokinetics and pharmacodynamics of recombinant IL-7 in these patients.
- Compare the biological and clinical effects of recombinant IL-7 with non-glycosylated IL-7 in these patients.
- Determine the potential antitumor effect of recombinant IL-7 in these patients.
- Determine the dose and administration schedule of recombinant IL-7 in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
结局指标
主要结局
Safety of recombinant interleukin-7 (IL-7)
次要结局
- Pharmacokinetics and pharmacodynamics of IL-7
- Comparison of the biological and clinical effects of recombinant IL-7 with non glycosylated IL-7
- Potential antitumor effect of recombinant IL-7
- Dose and administration schedule of recombinant IL-7
研究者
研究点 (2)
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