A Phase II Trial to Determine the Safety, Tolerability and Efficacy of an Allogeneic Whole Cell Vaccine Administered With Autologous Myeloid Dendritic Cells to Patients With Non-Metastatic Androgen Independent Prostate Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of Participants Who Are Progression Free at One Year
研究概览
简要总结
RATIONALE: Vaccines made from tumor cells or dendritic cells may help the body build an effective immune response to kill tumor cells. It is not yet known which vaccine is more effective in treating patients with prostate cancer.
PURPOSE: This phase II trial is studying how well the combination of a proven effective allogenic whole prostate carcinoma cell (APCC) vaccine co-administered with ex vivo generated dendritic cells (DCs)(DC-APCC) extend the time to prostate cancer progression.
详细描述
OBJECTIVES:
Primary
- Determine the proportion of patients with androgen-independent prostate cancer who are progression-free at one year after treatment with DC-APCC.
Secondary
- Evaluate treatment toxicity.
- Evaluate time to prostate-cancer specific mortality.
- Evaluate progression-free survival.
- Evaluate time to PSA progression, and duration of PSA-based response.
- Evaluate quality of life of patients treated with this regimen.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Participants Who Are Progression Free at One Year
时间窗: One year
Progression free was defined as being free of radiographically detectable disease/metastases at one year after registration and having a prostate-specific antigen (PSA) level \<200.0 ng/mL.
次要结局
- Change From Baseline in Quality of Life (QOL) as Measured by the EORTC QLQ-C30 Questionnaire(Baseline and cycle 1)
- Progression Free Survival (PFS)(Up to 3 years)
- Number of Participants With Severe Adverse Events(Every cycle during treatment (up to 14 cycles))
- Time to Prostate-cancer Specific Mortality(Registration to Prostate-cancer specific mortality (Up to 3 years))
- Time to Prostate-specific Antigen (PSA) Progression(Registration to PSA progression (Up to 3 years))
- Duration of PSA-based Response(Up to 3 years)