NCT00072098终止1 期
Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
Max Sung1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2003年9月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- safety measure
研究概览
简要总结
RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.
详细描述
OBJECTIVES:
- Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer .
- Determine the tumor response in patients treated with this regimen.
- Determine the immune response in 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 —（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 measure
时间窗: up to day 57
adverse event reporting
toxicity grading
时间窗: up to day 57
toxicity will assessed from grades 0 to 4 as per common toxicity criteria
次要结局
- tumor response compared at four weeks to baseline(baseline and four weeks)
研究者
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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