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Vitamin D Analog

Calcipotriene + 5-Fluorouracil for Actinic Keratosis

Phase 2

Recruiting

Led By Shadmehr Demehri

Research Sponsored by University of Arizona

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

Must not have

Participants with known history of chronic hepatitis B, or hepatitis C

OTRs with any sign of organ rejection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of chronic hepatitis B or C.

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I am an organ transplant recipient showing signs of organ rejection.

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I have skin growths that are thick, hard, or didn't improve with freezing treatments.

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My treatment area is close to a healing wound or a possible skin cancer spot.

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I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

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I have a history of high calcium levels or vitamin D toxicity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Induction of CD4+ TRM cells (CD3+CD4+CD103+) in the actinic keratosis

Secondary study objectives

Differences in AK clearance

Erythema extent and intensity scores of the treated anatomical sites

Incidence of adverse events

+2 more

Other study objectives

Compare the immune infiltrate in any SCC

Effect of number and type of field therapy and the number of cryotherapies

Percentage of participants with new diagnosis of SCC on the treated anatomical sites

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

Biopsy

2014

Completed Phase 4

~1150

Calcipotriene

2013

Completed Phase 3

~1340