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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and within 28 days
Awards & highlights
Study Summary
This trial is testing whether colchicine, a medication typically used to treat gout, can help to reduce inflammation in patients with solid tumors or localized urothelial cancer. There will be two groups of patients, those with metastatic solid tumors and those who have had surgery for localized urothelial cancer. The primary outcome measure is the reduction in levels of C-reactive protein (CRP), a marker of inflammation, after three cycles of colchicine treatment.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Change in Peripheral blood CRP level
Side effects data
From 2021 Phase 4 trial • 280 Patients • NCT017099811%
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
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,231 Total Patients Enrolled
Deborah DoroshowPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer has spread to my brain.My cancer type has been confirmed by lab tests.I am a woman who can have children and I have a negative pregnancy test from the last two weeks.My recent tests show my organs are functioning well.I am approved for and scheduled to receive nivolumab as part of my treatment plan.I finished my last cancer treatment over 30 days ago and have recovered from its side effects.I am currently being treated for an autoimmune disease like rheumatoid arthritis or lupus.I can provide tumor samples in blocks or slides for testing.I can care for myself and perform daily activities, possibly with some difficulty.I am HIV-positive, on effective treatment, and my viral load is undetectable.My cancer has spread or come back.My hepatitis B is under control, or I've been cured of hepatitis C.I am already on long-term colchicine treatment.I require treatment with specific drugs that affect how other drugs are broken down in my body.I had surgery to remove my bladder or parts of my urinary system due to urothelial cancer.I have had a heart attack in the last 6 months or have severe heart failure.I understand and can follow the study's procedures.I am currently being treated for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1 high-dose colchicine
- Group 2: Cohort 2 Participants with post-radical surgery
- Group 3: Cohort 1 low-dose colchicine
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are included in these proceedings?
"That is correct. The study, which can be found on clinicaltrials.gov, was originally posted on February 14th, 2022 and updated less than a month ago on March 5th. They are looking for 45 patients to participate at 1 location."
Answered by AI
Can new patients enroll in this research program?
"Yes, this is an active trial that was first posted on February 14th, 2022. The listing was edited most recently on March 5th, which currently seeks 45 total participants at a single site."
Answered by AI
What is the latest development in Colchicine's regulatory status?
"Colchicine's safety is based on limited data from Phase 1 trials, making it a score of 1."
Answered by AI
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