What side effects are associated with this type of intervention?

Common treatments for bladder cancer include intravesical chemotherapy with agents like mitomycin and gemcitabine. Mitomycin can cause self-limited chemical cystitis in about 40% of patients and a hypersensitivity rash, primarily on the palms, soles, and genitalia. Gemcitabine has a better toxicity profile compared to mitomycin, with fewer serious adverse events reported. Colchicine, being studied for its anti-inflammatory effects, is not typically used for bladder cancer, but its known side effects include gastrointestinal issues and potential impacts on wound healing.

What prior FDA approvals exist?

FDA-approved treatments for bladder cancer include a variety of chemotherapeutic agents and immunotherapies. Notably, pembrolizumab and atezolizumab are immune checkpoint inhibitors approved for advanced urothelial carcinoma, which is a common type of bladder cancer. These drugs work by enhancing the body's immune response against cancer cells. Additionally, enfortumab vedotin, an antibody-drug conjugate, has been approved for patients who have previously received immunotherapy and chemotherapy. While these treatments do not specifically focus on anti-inflammatory effects through CRP reduction, they represent significant advancements in the management of bladder cancer.

What other types of research exist?

Promising novel alternatives to Colchicine for bladder cancer patients include Oncofid-P-B, which has shown high efficacy and safety in BCG-unresponsive CIS patients, and immune checkpoint inhibitors like Pembrolizumab and Atezolizumab, which have demonstrated effectiveness in advanced urothelial carcinoma. Additionally, Rapamycin, an mTOR inhibitor, has shown potential in reducing neoplastic potential in urothelial carcinoma.

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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

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and within 28 days

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

Chest pain

Ischemic stroke

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Colchicine

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 12Eligibility criteria met

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.