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ACTIVE NOT RECRUITING
NCT05699603
PHASE2

Testing the Efficacy of Topical Calcipotriene Plus 5-Fluorouracil Combination to Activate the Immune System Against Precancerous Skin Lesions in Organ Transplant Recipients

Sponsor: University of Arizona

View on ClinicalTrials.gov

Summary

This phase IIA study evaluates the effects of calcipotriene plus 5- fluorouracil immunotherapy for skin cancer prevention in organ transplant recipients. Solid organ transplant recipients are at high risk of developing skin cancer. Actinic keratosis (AK), is a premalignant skin lesion that can progress to squamous cell skin cancer. In this study, solid organ transplant recipients with multiple AKs are treated with topical calcipotriene and 5-FU to evaluate how effective this therapy is against AKs and if this could lower their risk of skin cancer. Topical calcipotriene is a form of vitamin D and is used to treat psoriasis. Prior research reported immunomodulatory effects in the skin induced by topical calcipotriene. Topical 5- fluorouracil is a chemotherapy agent and is one of the therapy options for multiple AKs in specific clinical scenarios. Prior research indicates that topical calcipotriene used together with topical 5-FU was more effective in treating multiple AKs than 5-FU alone in individuals with healthy immune system. This study is investigating now if similar beneficial effects can be seen in immunosuppressed individuals who are solid organ transplant recipients.

Official title: Phase IIA, Single-Arm, Open- Label, Clinical Trial of Calcipotriene Plus 5-fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2024-07-02

Completion Date

2029-02-01

Last Updated

2025-09-24

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy

Undergo skin biopsy

DRUG

Calcipotriene

Applied topically

DRUG

Fluorouracil

Applied topically

Locations (4)

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Oregon Health and Science University

Portland, Oregon, United States