A Phase I/II Trial of ACA 125 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 21
- 主要终点
- Safety, feasibility and tolerability
研究概览
简要总结
The purpose of this study is to use an immunologic approach following the treatment for recurrent disease in patients with ovarian, fallopian tube, or peritoneal cancer.
详细描述
Patients with epithelial ovarian, fallopian tube or peritoneal cancer who receive surgical cytoreduction and platinum/taxane containing chemotherapy have a significant chance of entering complete clinical remission but about 70% will eventually relapse. Many patients respond to additional cytotoxic treatment with partial or complete responses, yet approximately 100% of these patients will ultimately progress. Novel consolidation strategies following treatment for recurrent disease are needed and an immunologic approach is an attractive option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, stages I-IV. These patients must have received initial surgery and chemotherapy with at least one platinum based chemotherapy regimen.
- •Patients must have relapsed and now have completed chemotherapy for recurrent disease within the last 6 weeks.
- •Eligible patients may have asymptomatic residual measurable disease on CT scan, and/or may have an elevated CA-125, or may be in complete clinical remission.
- •Patients must have adequate hematologic, renal and hepatic functions.
排除标准
- •Patients with any other active malignancy concomitantly
- •Patients within 3 weeks of prior cytotoxic or investigational chemotherapy
- •Patients within 4 weeks of prior radiotherapy
- •Patients within 6 weeks of prior immunotherapy
- •Patients who have received any prior anti-cancer vaccine
结局指标
主要结局
Safety, feasibility and tolerability
The primary endpoint is drop-out due to toxicity as the overall measure of feasibility
次要结局
- Duration and strength of the immune response induced by ACA 125 vaccination