An Exploratory Clinical Trial of Zoledronic Acid in Women With CIN 2/3 or 3
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Impact of Zoledronic Acid (ZA) on clinical response
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep tumors from forming, growing, or coming back. Zoledronate may prevent the growth of cervical cancer by blocking blood flow to cervical intraepithelial neoplasia cells. The use of zoledronate may keep cancer from forming.
PURPOSE: This randomized is studying how well zoledronate works in treating patients with cervical intraepithelial neoplasia 2/3 or 3.
详细描述
OBJECTIVES:
- Assess clinical response, in terms of lesion size and histological grade, of oledronate in patients with cervical intraepithelial neoplasia 2/3 or 3.
OUTLINE: This is a randomized, placebo-controlled, double-blind, pilot study. Patients are stratified according to degree of cervical intraepithelial neoplasia (CIN) (CIN2/3 vs CIN3). Patients are randomized to 1 of 2 treatment arms.
- Zoledronate: 100 cc of saline with 4 mg of Zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart
- Placebo: 100 cc of saline (IV), over 20 minutes, for 3 doses one week apart
In both arms, treatment repeats every 21 days for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Zoledronate
100 cc of saline with 4 mg of zoledronate intravenous (IV), over 20 minutes, for 3 doses one week apart
Treatment repeats every 21 days (one course) for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy.
After completion of study treatment, patients are followed at week 10 by telephone.
干预措施: Zoledronate (Drug)
Saline
100 cc of saline IV, over 20 minutes, for 3 doses one week apart
Treatment repeats every 21 days (one course) for up to 3 courses. In week 8, patients undergo surgical resection comprising loop excision or cone biopsy.
After completion of study treatment, patients are followed at week 10 by telephone.
干预措施: Placebo (Saline) (Other)
结局指标
主要结局
Impact of Zoledronic Acid (ZA) on clinical response
时间窗: 10 weeks from start of treatment
The primary objective is to determine whether Zoledronic Acid (ZA), when given to women with CIN 2/3 or 3 for two months prior to surgical excision, has a measurable impact on clinical response (lesion size and histological grade).
次要结局
未报告次要终点