A Phase I/II Clinical Trial of pNGVL4a-Sig/E7 (Detox)/HSP70 for the Treatment of Patients With HPV 16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Safety and Toxicity
研究概览
简要总结
RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility and toxicity of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine in preventing cervical cancer in patients with human papillomavirus (HPV)-16-positive grade 2 or 3 cervical intraepithelial neoplasia.
- Determine the effect of this vaccine on the histology of cervical tissue specimens from these patients.
Secondary
- Determine changes in lesion size and HPV viral load in patients treated with this vaccine.
- Determine the cellular, humoral, and local tissue immune responses in patients treated with this vaccine.
- Correlate measures of immune response with clinical response in patients treated with this vaccine.
- Correlate measures of immune response in patients treated with this vaccine with those observed in the preclinical model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
Low dose
3-500mcg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals.
Genetic (recombinant DNA vaccine)
干预措施: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine (Biological)
Intermediate dose
3-1mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
干预措施: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine (Biological)
High dose
3-3mg doses of pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine administered IM at one month intervals Genetic (recombinant DNA vaccine)
干预措施: pNGVL4a-Sig/E7(detox)/HSP70 DNA vaccine (Biological)
结局指标
主要结局
Safety and Toxicity
时间窗: for the duration of the study, and whenever possible, for an additional 5 years
Number of participants with serious adverse events (SAE) according to CTCAE 3.0 grading.
Efficacy
时间窗: for the duration of the study, and whenever possible, for an additional 5 years
The efficacy of pNGVL4a-SigE7(detox)HSP70 DNA vaccine, administered intra-muscularly. This is reported as number of participants with histologic regression of CIN2/3 to CIN1 or less by colposcopically-directed biopsy.
次要结局
- Regression of CIN3 Lesions(15 weeks)
- Number of Participants With T-cell Immune Responses in the Blood(41 weeks)
- Number of Participants With Correlated Measures of Immune Response With Clinical Response(9 months)
- Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model(9 months)