NCT02137746已完成2 期
Open-label, One-arm, Multi-centre Phase II Clinical Trial Treated With Second Cycle of Active Cellular Immunotherapy With DCVAC/PCa in Patients With Localized Prostate Cancer After Primary Radical Prostatectomy Without Objective Progression
SOTIO a.s.8 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- Safety evaluation of the second cycle of DCVAC
研究概览
简要总结
The purpose of this study is to assess the safety of the second cycle of DCVAC/PCa in patients who completed the first cycle of DCVAC/PCa in the clinical trial SP003 without an objective progression of the disease.
详细描述
Same as brief summary
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 18 years and older
- •Histologically confirmed prostate adenocarcinoma Stage pathological tumor-2 (pT2)
- •Post radical Primary Prostatectomy
- •Completion of DCVAC/PCa arm in Study SP003, without objective progression of the disease
排除标准
- •Prior androgen deprivation therapy for prostate cancer
- •Peripheral neuropathy of Common Toxicity Criteria (CTC) grade 2 or greater
- •Other uncontrolled intercurrent illness
- •Treatment with immunotherapy against PCa
- •Clinically significant cardiovascular disease
- •Active autoimmune disease requiring treatment
研究组 & 干预措施
DCVAC/PCa Arm
Experimental
Dendritic Cells DCVAC/PCa Experimental therapy
干预措施: Dendritic Cells DCVAC/PCa (Biological)
结局指标
主要结局
Safety evaluation of the second cycle of DCVAC
时间窗: 52 weeks
Safety evaluation of the second cycle of active cellular immunotherapy, which includes a second leukapheresis procedure, who after primary radical prostatectomy completed first cycle of active cellular immunotherapy in clinical trial SP003 without objective disease progression requiring additional anti-tumor therapy.
次要结局
- Time to Prostate Specific Antigen (PSA) Doubling Time(52 weeks)
研究者
研究点 (8)
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