Phase II Evaluation Of SGN-00101 (HSP-E7) Fusion Protein In Women With Cervical Intraepithelial Neoplasia 3, CIN 3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Complete histologic regression of all CIN 3 lesions
研究概览
简要总结
Vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. Randomized phase II trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia
详细描述
PRIMARY OBJECTIVES:
I. Determine the efficacy of SGN-00101, in terms of complete histologic regression, in patients with grade III cervical intraepithelial neoplasia.
II. Determine the toxicity of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine change in lesion size in these patients after treatment with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed grade III cervical intraepithelial neoplasia
- •Confirmed by biopsy or colposcopy
- •Positive for human papilloma virus 16
- •No endocervical glandular dysplasia
- •No adenocarcinoma in situ
- •Performance status - GOG 0-2
- •No life-threatening or serious hematological disorder
- •No life-threatening or serious hepatic disorder
- •No life-threatening or serious renal disorder
- •No life-threatening or serious cardiac disorder
- •No life-threatening or serious respiratory disorder
- •HIV negative
- •Must be immunocompetent
- •No history of autoimmune disease
- •No life-threatening or serious immunological disorder
- •No prior or concurrent severe allergic disease
- •No concurrent human papilloma viral infection other than type 16
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No life-threatening or serious gastrointestinal disorder
- •No life-threatening or serious endocrine disorder
- •No invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No concurrent chronic or systemic steroids
- •No prior organ transplantation
- •No prior cancer therapy that would preclude study therapy
排除标准
- 未提供
结局指标
主要结局
Complete histologic regression of all CIN 3 lesions
时间窗: Up to 3 years
Fisher's exact test (and if feasible, Chi-Square test) will be conducted to see if the probability of responding in the investigational arm is significantly different from the controls actively accrued to this study. The conditional distribution used in Fisher's exact test will be used to calculate a 90% confidence interval for the odds ratio of observing a response in the investigational arm to the control arm.
Frequency and severity of adverse events assessed by Common Toxicity Criteria (CTC) version 2.0
时间窗: Up to 3 years
次要结局
未报告次要终点