NCT00301106终止1 期
Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver
Max Sung1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2005年10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
- 2
- 试验地点
- 1
- 主要终点
- Toxicity
研究概览
简要总结
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
详细描述
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene (Adv.RSV-hIL12, also termed ADV-hIL-12).
OBJECTIVES:
- Study the toxicity of escalating doses of adenoviral vector expressing the human recombinant interleukin-12 gene, administered by percutaneous intratumoral injection, in women with liver metastasis secondary to breast cancer.
- Determine tumor responses produced by this regimen.
- Determine immune responses induced by 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 85 Years（Adult, Older Adult）
- 性别
- Female
- 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
Toxicity
时间窗: up to 15 days
Serial monitoring of tumor necrosis factor alpha (TNFα) levels
次要结局
- Tumor Response(up to 2 months)
- IFNγ levels Immune response(up to 2 months)
- Immune response(up to 2 months)
- IL12 level Immune response(up to 2 months)
研究者
Max Sung
Associate Professor
Icahn School of Medicine at Mount Sinai
研究点 (1)
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