A Phase I Study Of NY-ESO-1b Peptide Plus Montanide ® ISA-51 In Patients With Ovarian, Primary Peritoneal, Or Fallopian Tube Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Patients With Dose Limiting Toxicities (DLTs)
研究概览
简要总结
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: A phase I trial to study the side effects of vaccine therapy in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
详细描述
OBJECTIVES:
- Determine the safety of NY-ESO-1b peptide vaccine and Montanide® ISA-51 in patients with ovarian epithelial, primary peritoneal, or fallopian tube cancer.
- Determine the immunologic profile (NY-ESO-1 antibody, CD8+ cells, and delayed-type hypersensitivity) induced by this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive NY-ESO-1b peptide vaccine emulsified with Montanide® ISA-51 subcutaneously once every 3 weeks on weeks 1, 4, 7, 10, and 13 in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3 weeks (week 16) and then every 6-12 weeks for 2 years or until disease progression.
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
- 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
Number of Patients With Dose Limiting Toxicities (DLTs)
时间窗: up to 16 weeks
Toxicities and adverse events defined by National Cancer Institute Common Toxicity Criteria (CTC) Scale (Version 2.0, published April 30, 1999). DLT defined as: ≥ Grade 2 autoimmune phenomena, asymptomatic bronchospasm or generalized urticaria, or ≥ Grade 3 hematological and non hematological toxicities. To be dose-limiting, an adverse event must be definitely, probably, or possibly related to the administration of the investigational agent.
次要结局
- Number of Patients With NY-ESO-1b-Specific Activated CD8+ T Cells Measured by ELISPOT(up to 16 weeks)
- Number of Patients Developing NY-ESO-1 Antibodies After Treatment(up to 16 weeks)
- Number of Patients With NY-ESO-1b-Specific CD8+ T Cells Measured by Tetramer Analysis(up to 16 weeks.)
- Number of Patients With NY-ESO-1b-specific Delayed-type Hypersensitivity (DTH)(up to 16 weeks)