NCT00140374已完成1 期
Phase I/II Study of Vaccination Priming and Vaccine Boosting With Allogeneic Human GM-CSF Gene Transduced Irradiated Prostate Cancer Cell Vaccines in Patients With Prostate Cancer
Cell Genesys0 个研究点目标入组 36 人开始时间: 1998年12月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of priming vaccinations, and subsequent boosting vaccinations with GVAX® Vaccine for Prostate Cancer. Clinical observations and laboratory measurements will be monitored to evaluate safety and toxicity. Additionally, the antitumor effects of GVAX® Vaccine for Prostate Cancer on serum PSA levels, will be evaluated and antitumor responses will be quantitated.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adenocarcinoma prostate cancer that has recurred after surgery by PSA
- •No evidence of measurable metastatic disease
- •An ECOG performance status of 0 or 1
排除标准
- •Transitional cell, small cell or squamous cell prostate carcinomas
- •Any previous radiation therapy, prior anti-androgens or prior investigational therapy
- •Previous hormonal therapy of any type for prostate cancer
- •Previous biological therapy for cancer
研究者
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