NCT00041626Unknown3 期
Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone
Introgen Therapeutics16 个研究点 分布在 1 个国家开始时间: 2002年7月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 16
研究概览
简要总结
There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •18 years or older
- •Must have had radiation treatment
- •Eligible for chemotherapy
- •Not eligible for surgery
排除标准
- 未提供
研究者
研究点 (16)
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