Colchicine to Suppress Pro-tumorigenic Inflammation in Patients with Urothelial Cancer and Other Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percent Change in Peripheral blood CRP level
研究概览
简要总结
This open-label, non-randomized study aims to determine the anti-inflammatory effect of colchicine on the reduction of peripheral blood CRP in patients with solid tumors or localized urothelial cancer. There are two cohorts, which will enroll separately and parallelly. Cohort 1 will include two successive groups with advanced/recurrent solid tumors (15 patients will receive low-dose colchicine and 15 for high-dose colchicine) who will receive 14 days of colchicine. In Cohort 2, 15 patients with post-radical surgery for high-risk clinically localized urothelial cancer will be enrolled. They will receive one 28-day cycle of colchicine. The primary outcome, post-treatment decline in CRP level, a continuous measure, will be defined as the maximum percentage decline from baseline in post-treatment CRP value within two weeks of colchicine (Cohort 1) or one cycle of colchicine (cohort 2), where the baseline value is measured before any treatment is initiated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 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
Cohort 1 high-dose colchicine
Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID)
干预措施: Colchicine (Drug)
Cohort 1 low-dose colchicine
Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID)
干预措施: Colchicine (Drug)
Cohort 2 Participants with post-radical surgery
Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID.
干预措施: Colchicine (Drug)
结局指标
主要结局
Percent Change in Peripheral blood CRP level
时间窗: Baseline and Within 28 days
The primary outcome, post-treatment decline in peripheral blood CRP level, a continuous measure, will be defined as the maximum percent decline of post-treatment CRP from baseline obtained during the treatment period, where the baseline value is measured before any treatment initiated For a patient with an advanced/recurrent solid tumor who receive 2-weeks of treatment, it will be the maximum percentage decline during the 28 days of treatment. For a patient who receive colchicine less than 28 days, it will be the maximum percentage decline from baseline to the last day of treatment.
次要结局
未报告次要终点
研究者
Deborah Doroshow
Assistant Professor
Icahn School of Medicine at Mount Sinai
