SGN-00101 (HspE7) Immunotherapy Of CIN III
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Rate of regression
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia.
PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.
详细描述
OBJECTIVES:
Primary
- Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.
- Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.
- Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.
Secondary
- Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine
- Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.
- Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.
- Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
研究组 & 干预措施
2 month follow-up
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy
干预措施: HspE7 (Biological)
1 month follow-up
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
干预措施: HspE7 (Biological)
结局指标
主要结局
Rate of regression
时间窗: 4 months after completion of treatment
Toxicity
时间窗: 4 months after completion of treatment
次要结局
未报告次要终点