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Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients

NCT04329221 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-05-07

No results posted yet for this study

Summary

This clinical trial aims to investigate the efficacy of Calcipotriol ointment combined with 5-fluorouracil cream as an immunotherapy for actinic keratosis in Organ Transplant Recipients (OTRs) before transplantation and determine whether it can prevent cutaneous squamous cell carcinoma (SCC) in OTRs post-transplant.

Conditions

Interventions

DRUG

Calcipotriol Only Product in Cutaneous Dose Form

Calcipotriol (Calcipotriene) is a form of vitamin D. It works by inducing thymic stromal lymphopoietin cytokine expression in the skin.

DRUG

Vaseline

Placebo

DRUG

Topical 5FU

5-FU is a chemotherapy that causes the death of proliferating tumor cells. Topical preparation of this drug is being used.

Sponsors & Collaborators

  • Washington University School of Medicine

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Shadmehr Demehri, MD/PHD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2029-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329221 on ClinicalTrials.gov