NCT00140400已完成1 期
Phase I/II Study of a Prime-Boost Schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) in Hormone-Refractory Prostate Cancer
Cell Genesys0 个研究点目标入组 50 人开始时间: 1999年5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
- 50
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of a prime-boost dose schedule of Human GM-CSF Gene Transduced Irradiated Prostate Allogeneic Cancer Vaccine (Allogeneic Prostate GVAX®) as measured by standard toxicity evaluation, changes in PSA, and tumor responses. Additional objectives are to measure the time to PSA and/or clinical disease progression as well as local and systemic immune responses to the vaccine.
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
- •Prostate cancer deemed to be unresponsive or refractory to hormone therapy
- •An ECOG performance status of 0 or 1
排除标准
- •Transitional cell, small cell, neuroendocrine, or squamous cell prostate cancer
- •Previous chemotherapy, biological or immunotherapy for cancer
- •Previous gene therapy for cancer
- •Significant cancer related pain
研究者
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