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Anti-inflammatory agent

Colchicine for Bladder Cancer

Phase 1
Recruiting
Led By Deborah Doroshow
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years at the time of consent.
Histological or cytologically confirmed solid tumor for patients in Cohort 1.
Must not have
Active central nervous system (CNS) metastases.
Rheumatoid arthritis, vasculitis, systemic lupus erythematosus, or other autoimmune condition requiring active systemic treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and within 28 days
Awards & highlights

Summary

This trial tests colchicine, a medication that reduces inflammation, in patients with advanced solid tumors or high-risk localized urothelial cancer after surgery. The goal is to see if colchicine can lower CRP levels, a marker of inflammation, in these patients. Colchicine has been used to reduce inflammation in various conditions, including gout and post-cardiac surgery complications.

Who is the study for?
Adults with advanced solid tumors or high-risk localized urothelial cancer post-surgery, who have not taken colchicine long-term or had recent cancer treatments. They must have a certain level of organ function and agree to use contraception. Excluded are those with active brain metastases, infections needing systemic therapy, autoimmune conditions requiring treatment, recent heart issues, or pregnant/breastfeeding individuals.
What is being tested?
The trial is testing the anti-inflammatory effects of colchicine on patients with solid tumors (Cohort 1) and localized urothelial cancer (Cohort 2). Cohort 1 will receive low or high doses for two weeks; Cohort 2 gets one cycle for four weeks. The main goal is to see how much colchicine can lower CRP levels in the blood.
What are the potential side effects?
Colchicine may cause gastrointestinal symptoms like diarrhea and nausea, blood disorders such as low white cell counts leading to increased infection risk, muscle pain/weakness, and rarely more serious conditions like bone marrow suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer type has been confirmed by lab tests.
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I am HIV-positive, on effective treatment, and my viral load is undetectable.
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My cancer has spread or come back.
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My hepatitis B is under control, or I've been cured of hepatitis C.
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I had surgery to remove my bladder or parts of my urinary system due to urothelial cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my brain.
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I am currently being treated for an autoimmune disease like rheumatoid arthritis or lupus.
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I am already on long-term colchicine treatment.
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I require treatment with specific drugs that affect how other drugs are broken down in my body.
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I have had a heart attack in the last 6 months or have severe heart failure.
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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and within 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and within 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent Change in Peripheral blood CRP level

Side effects data

From 2021 Phase 4 trial • 280 Patients • NCT01709981
1%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2 Participants with post-radical surgeryExperimental Treatment1 Intervention
Participants with post-radical surgery for high-risk clinically localized urothelial cancer will receive colchicine 0.6 mg oral BID.
Group II: Cohort 1 low-dose colchicineExperimental Treatment1 Intervention
Participants with advanced/recurrent solid tumors who will receive low-dose colchicine (0.6 mg oral BID)
Group III: Cohort 1 high-dose colchicineExperimental Treatment1 Intervention
Participants with metastatic solid tumors who will receive high-dose colchicine (0.6 mg oral TID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bladder cancer treatments often target the tumor's growth and spread through various mechanisms. Chemotherapy uses drugs to kill rapidly dividing cancer cells, while immunotherapy, such as intravesical BCG, stimulates the immune system to attack cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells. Colchicine, being studied for its anti-inflammatory effects, aims to reduce CRP levels, potentially decreasing inflammation and tumor progression. Understanding these mechanisms is crucial for bladder cancer patients as it helps tailor treatments to individual needs, potentially improving outcomes and minimizing side effects.
RNA-based urinary assays for non-muscle invasive bladder cancer.[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.]Targeting mTOR and p53 Signaling Inhibits Muscle Invasive Bladder Cancer In Vivo.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
893 Previous Clinical Trials
536,873 Total Patients Enrolled
Deborah DoroshowPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

Colchicine (Anti-inflammatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT05279690 — Phase 1
Bladder Cancer Research Study Groups: Cohort 1 high-dose colchicine, Cohort 2 Participants with post-radical surgery, Cohort 1 low-dose colchicine
Bladder Cancer Clinical Trial 2023: Colchicine Highlights & Side Effects. Trial Name: NCT05279690 — Phase 1
Colchicine (Anti-inflammatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05279690 — Phase 1
~1 spots leftby Dec 2024