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Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors

Metastatic Solid Tumor Clinical Trial

Official title:
Colchicine to Suppress Pro-tumorigenic Inflammation in Patients With Urothelial Cancer and Other Solid Tumors

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05279690
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Natalie Lucas
Phone 929-489-5016
Email natalie.lucas@mssm.edu
Status Recruiting
Phase Phase 1
Start date February 14, 2022
Completion date December 2024
View Details
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