A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded With Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
This is a Five cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube, or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide or in combination with intravenous Bevacizumab, cyclophosphamide and aspirin. Study duration is 24 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 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
时间窗: 30 days of last vaccination
Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version3.0). All toxicities observed within 30 days of last vaccination will be included.
次要结局
- Dose limiting toxicity
- Clinical Response
- Immune Response Immune Response