NCT05279690

Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors

Colchicine to Suppress Pro-tumorigenic Inflammation in Patients with Urothelial Cancer and Other Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Urothelial Cancer
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	Colchicine	Patients will receive 14 days of colchicine in the absence of prohibitive toxicity of disease progression

Timeline

• Start date: 2022-02-14
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2022-03-15
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study