A Phase I Proof-of-Concept Study of Artesunate Ointment for the Treatment of Patients With High-Grade Vulvar Intraepithelial Neoplasia (HSIL VIN 2/3)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
研究概览
简要总结
This is a Phase I, proof-of-concept treatment study to evaluate the safety, tolerability and feasibility of topical artesunate ointment to treat high grade vulvar intraepithelial neoplasia (HSIL VIN2/3).
详细描述
Phase I open-label dose escalation study of topical artesunate, formulated as ointment, in the treatment of adult females with biopsy-confirmed HSIL VIN2/3. Fifteen (15) subjects will undergo up to a total of three cycles of topical artesunate. The first cycle will be initiated on Day 0, the second at Week 2, and the third and final cycle at week 4.
Primary Objective:
To evaluate the safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions
To measure the effect of artesunate ointment on histologic regression of HSIL/VIN2/3 to VIN1 or less, confirmed by a colposcopically-directed biopsy, at study week 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Colposcopically-directed biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2/3, HSIL), including both new and recurrent disease.
- •Females of childbearing potential: negative urine pregnancy test
- •Ability to provide informed consent
- •Ability to collaborate with planned follow-up (transportation, compliance history, etc.)
- •Use of contraception through the study exit visit (week 28)
排除标准
- •Concomitant use of any topical immune modulating agents e.g. imiquimod, Aldara ®
- •Cluster of differentiation 4 (CD4) count < 200 at the time of screening for eligibility.
- •Unable to provide informed consent
- •Currently receiving systemic chemotherapy or radiation therapy for another cancer.
- •Pregnant females
- •Concurrent dermatological disorders involving the vulva (i.e., herpes, ulceration secondary to Crohn's disease) or vulvar dermatosis (i.e., lichen planus, lichen sclerosus, or lichen simplex chronicus);
- •Women weighing less than 50 kg
研究组 & 干预措施
Artesunate ointment 40%, 1 cycle
Patients enrolled in this treatment group will receive one 5-day cycle of artesunate ointment applied topically to the vulva at week 0.
干预措施: artesunate ointment 40% (Drug)
Artesunate ointment 40%, 2 cycles
Patients enrolled in this treatment group will receive two 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0 and 2.
干预措施: artesunate ointment 40% (Drug)
Artesunate ointment 40%, 3 cycles
Patients enrolled in this treatment group will receive three 5-day cycles of artesunate ointment applied topically to the vulva at weeks 0, 2, and 4.
干预措施: artesunate ointment 40% (Drug)
结局指标
主要结局
Safety and tolerability of artesunate ointment applied topically on VIN2/3 lesions as assessed by number of participants experiencing serious adverse events or dose-limiting toxicities
时间窗: 15 weeks
Number of participants with study-related serious adverse events or dose-limiting toxicities assessed using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) criteria
次要结局
- Effect of artesunate ointment as assessed by number of participants with regression to VIN1 or less at week 15(15 weeks)