Pilot Trial of Colchicine in Urothelial Cancer and Other Solid Tumors

Phase 1

Completed

• Conditions: Urothelial Cancer; Metastatic Solid Tumor
• Interventions: Drug: Colchicine

• Registration Number: NCT05279690
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-03-05
• Study First Submitted QC: 2022-03-05
• Study First Posted: 2022-03-15
• Status Verified: 2024-12
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Last Update Submitted: 2024-12-22
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 low-dose colchicine	Colchicine	Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID)
Cohort 1 high-dose colchicine	Colchicine	Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID)
Cohort 2 Participants with post-radical surgery	Colchicine	Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID.

Primary Outcome Measures

Name	Time	Method
Percent Change in Peripheral blood CRP level	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.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States