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Vitamin D Analog
Calcipotriene + 5-Fluorouracil for Actinic Keratosis
Phase 2
Recruiting
Led By Shadmehr Demehri
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presence of four to fifteen clinically typical, visible, and discrete AKs in 25 cm^2 on specific anatomical sites
Baseline respiratory requirement for lung transplant recipients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial tests an immune-based therapy to help prevent skin cancer in organ transplant recipients.
Who is the study for?
This trial is for organ transplant recipients who've had a kidney or lung transplant at least 2 years ago, are stable, and have 4-15 visible precancerous skin lesions. Participants must be adults with good overall health and blood counts within specific ranges. Pregnant women, those with recent cancer treatments, uncontrolled illnesses, certain infections or allergies to the study drugs cannot join.Check my eligibility
What is being tested?
The study tests if a cream combining calcipotriene (a vitamin D form) and chemotherapy agent 5-fluorouracil can activate immune cells against precancerous skin lesions to prevent skin cancer in organ transplant patients.See study design
What are the potential side effects?
Potential side effects may include local skin reactions like redness, irritation or peeling where the cream is applied. There's also a risk of more systemic effects due to absorption such as changes in blood calcium levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have 4 to 15 visible skin lesions in a specific area of my body.
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I am a lung transplant recipient meeting the initial lung function criteria.
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I am not able to become pregnant or I have a negative pregnancy test.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Induction of CD4+ TRM cells (CD3+CD4+CD103+) in the actinic keratosis
Secondary outcome measures
Differences in AK clearance
Erythema extent and intensity scores of the treated anatomical sites
Incidence of adverse events
+2 moreOther outcome measures
Compare the immune infiltrate in any SCC
Comparison of the immune induction outcomes in AKs versus the normal skin samples
Effect of number and type of field therapy and the number of cryotherapies
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (calcipotriene, fluorouracil)Experimental Treatment3 Interventions
Participants receive calcipotriene plus fluorouracil cream topically BID for 6 consecutive days on study. Participants also undergo skin biopsies throughout the study. Patients who continue to experience AKs at week 8 may receive a second course of calcipotriene plus fluorouracil cream topically BID for 6 consecutive days on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Biopsy
2014
Completed Phase 4
~1090
Calcipotriene
2013
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,672 Previous Clinical Trials
40,926,385 Total Patients Enrolled
Shadmehr DemehriPrincipal InvestigatorUniversity of Arizona Cancer Center - Prevention Research Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV.I had a kidney or lung transplant over 2 years ago and my transplant is stable.Your white blood cell count is between 3,000 and 12,000 per microliter.You have had allergic reactions to similar medicines like calcipotriene and 5-FU.I have a history of chronic hepatitis B or C.I have 4 to 15 visible skin lesions in a specific area of my body.I am an organ transplant recipient showing signs of organ rejection.I have skin growths that are thick, hard, or didn't improve with freezing treatments.I have been treated with calcipotriene plus 5-FU within the last year.My treatment area is close to a healing wound or a possible skin cancer spot.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I have a history of high calcium levels or vitamin D toxicity.I am a lung transplant recipient meeting the initial lung function criteria.I am not able to become pregnant or I have a negative pregnancy test.I am 18 years old or older.I can care for myself but may not be able to do active work.I am willing and able to participate in the study.Your creatinine levels are within the normal range for the testing done at the hospital.Your platelet count is at least 100,000 per microliter.I haven't had cancer treatment or radiation in the last year.You have enough infection-fighting white blood cells in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (calcipotriene, fluorouracil)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there numerous medical facilities conducting this trial in the United States?
"This clinical trial is accepting participants from Dana-Farber Cancer Institute in Boston, Washington University School of Medicine in Saint Louis, and Oregon Health and Science University in Portland. There are 4 other locations that are also participating."
Answered by AI
Has the FDA issued a statement of approval for Prevention (calcipotriene, fluorouracil)?
"Our team at Power has assessed the safety of Prevention (calcipotriene, fluorouracil) to be a 2 out of 3. This is due to Phase 2 evidence supporting its safety but no available data investigating efficacy."
Answered by AI
Are there any openings present in this medical experiment?
"Clinicaltrials.gov discloses that this trial, which was initially published on the 10th of July 2023 and revised 25 days later, is no longer seeking participants. Fortunately, 27 other trials are currently enlisting patients into their studies."
Answered by AI
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