NCT00075569已完成2 期
SGN-00101 (HspE7) Immunotherapy Of CIN III
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions
- •No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •WBC at least 3,500/mm^3
- •Lymphocyte count at least 500/mm^3
- •Platelet count at least 150,000/mm^3
- •Hemoglobin at least 10 g/dL
- •No significant hematologic disease that is uncontrolled with standard therapy
- •Bilirubin no greater than 2 mg/dL
- •Liver enzymes no greater than 2.5 times normal
- •No significant hepatic disease that is uncontrolled with standard therapy
- •Creatinine no greater than 2 mg/dL
- •No significant renal disease that is uncontrolled with standard therapy
- •Cardiovascular
- •No significant cardiovascular disease that is uncontrolled with standard therapy
- •No significant respiratory disease that is uncontrolled with standard therapy
- •No history of asthma
- •Immunologic
- •HIV negative
- •No clinical evidence of immunosuppression
- •No autoimmune disease
- •No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study
- •No history of a positive purified protein derivative (PPD) or Tine test
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile
- •No uncontrolled chronic disease
- •Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs
- •No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy
- •No other underlying or unstable disease that would be exacerbated by the study treatment
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior BCG vaccination
- •No other concurrent vaccine therapy
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •More than 30 days since prior oral or parenteral glucocorticoid steroid
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 30 days since prior participation in another investigational study
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
2 month follow-up
Active Comparator
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
Active Comparator
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
研究者
研究点 (2)
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