EUCTR2009-017259-91-CZ进行中（未招募）不适用
Phase I/II clinical trial: Immunotherapy of prostate cancer patients in biochemical relapse with dendritic cell-based vaccine - Imunoterapie karcinomu prostaty dendritickými bunkami
niversity Hospital Motol0 个研究点开始时间: 2009年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Histological confirmed prostatic adenocarcinoma
- •Biochemical relapse after prostatectomy or radiotherapy
- •Absence of hormonal therapy
- •Karnofsky performance status more than 80%
- •Signed informed consent
- •Inclusion criteria for extension (for cycle 2 and following cycles):
- •Administration of at least 5 vaccines in the previous cycle
- •PSA=0.5 ng/ml
- •Signed informed consent for extension
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Stage T3a, T3b, T4 or any other T with N1 M1
- •HIV positivity, active B or C hepatitis
- •Severe cardiac or other internal disease limiting patient survival
- •History of primary immunodeficiency, active autoimmunity requiring treatment or anaphylactic reaction after previous vaccination
- •Negative informed consent
研究者
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