NCT00060099Unknown2 期
Phase II Randomized, Double-Blinded Trial Of SGN-00101 (HSP-E7) For Treatment Of CIN II/III
Dana-Farber/Brigham and Women's Cancer Center2 个研究点 分布在 1 个国家开始时间: 2003年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
详细描述
OBJECTIVES:
- Compare the efficacy of SGN-00101 vs placebo in patients with grade II or III cervical intraepithelial neoplasia.
- Correlate clinical response, as defined by histologic demonstration of lesion regression, with potential surrogate markers of vaccine efficacy (e.g., spectroscopic changes in the epithelium, development of human papilloma virus (HPV)-specific mucosal and systemic T-cell responses, and levels of HPV-specific antibody in cervical secretions), in patients treated with this drug.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive SGN-00101 subcutaneously (SC) once a month for 3 consecutive months in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive placebo SC as in arm I. Patients are followed monthly for 3 months after the last injection and then undergo large loop excision of the transformation zone under colposcopy at the fourth month. Patients with disease progression undergo immediate large loop excision.
PROJECTED ACCRUAL: A maximum of 80 patients (40 per treatment arm) will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed grade II or III cervical intraepithelial neoplasia
- •Confirmed by colposcopy-directed punch biopsy
- •Accessible, definable, and entirely visible cervical lesions persisting after biopsy
- •Satisfactory colposcopic exam within 3-6 weeks after diagnostic biopsy
- •Positive for human papilloma virus 16
- •CD4+ counts normal
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No coagulation disorder that requires medical intervention
- •Hepatitis B core antigen negative
- •Hepatitis C antibody negative
- •Not specified
- •Cardiovascular
- •No cardiovascular disorder that requires medical intervention
- •No respiratory disorder that requires medical intervention
- •Immunologic
- •HIV negative
- •Not immunologically compromised
- •No prior severe allergic reactions (anaphylactic response) to drugs or any other allergen
- •No immunological disorders including any of the following:
- •Multiple sclerosis
- •Myasthenia gravis
- •No active systemic infections that require medical intervention
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Willing to undergo a loop electrosurgical excision procedure
- •No medical or psychiatric illness that would preclude study treatment, ability to give informed consent, or study compliance
- •No other prior malignancy except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent immunotherapy
- •No other concurrent gene therapy
- •No concurrent biologic therapy
- •Chemotherapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •More than 30 days since prior systemic steroid therapy
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •More than 30 days since prior investigational drugs
- •No other concurrent investigational drugs
排除标准
- 未提供
研究者
研究点 (2)
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