NCT00074230已完成1 期
Vaccination of Stage IV Cutaneous Melanoma Patients With Mature, Autologous Monocyte-Derived Dendritic Cells Transfected With RNAs Encoding for Mage-3, MelanA, and Survivin Antigens
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Safety and tolerability at every visit
研究概览
简要总结
RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma.
- Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine.
- Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients.
Secondary
- Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine.
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
- All
- 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
Safety and tolerability at every visit
时间窗: 3 months
Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months
时间窗: 3 months
次要结局
- Time to progression as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
- Duration of response as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
- Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit(3 months)
- Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months(3 months)
研究者
PD Dr. med. univ. Beatrice Schuler-Thurner
Principal Investigator
University Hospital Erlangen
研究点 (2)
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