Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sulindac Concentration in the Nevi (Moles)
研究概览
简要总结
This randomized phase II trial is studying how well sulindac works in preventing melanoma in healthy participants who are at increased risk of melanoma. Sulindac may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether sulindac is more effective than a placebo in preventing melanoma in individuals with many moles and abnormal moles.
详细描述
PRIMARY OBJECTIVE:
I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.
SECONDARY OBJECTIVES:
I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.
II. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm II
Participants receive oral placebo twice daily for 8 weeks
干预措施: laboratory biomarker analysis (Other)
Arm II
Participants receive oral placebo twice daily for 8 weeks
干预措施: placebo (Other)
Arm I
Participants receive oral sulindac twice daily for 8 weeks
干预措施: sulindac (Drug)
Arm I
Participants receive oral sulindac twice daily for 8 weeks
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Sulindac Concentration in the Nevi (Moles)
时间窗: 8 weeks
Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi
时间窗: 8 weeks
Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi
时间窗: 8 weeks
次要结局
- Association Between Plasma and Target Tissue Sulindac Sulfide Levels(8 weeks)
- Sulindac Effects on Apoptosis in Atypical Nevi(Baseline and 8 weeks)
- Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi(Baseline and 8 weeks)
- Association Between Plasma and Target Tissue Sulindac Sulfone Levels(8 weeks)
- Association Between Plasma and Target Tissue Sulindac Levels(8 weeks)