Study on Using Immunotherapy Before Transplant to Prevent Skin Cancer in Organ Transplant Patients

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04329221

Provider View

This clinical trial is exploring whether a combination of Calcipotriol ointment and 5-fluorouracil cream can help prevent skin cancer in organ transplant patients by treating precancerous skin spots before the transplant.

Patient Parameters

Program Overview

The study aims to find out if using Calcipotriol ointment with 5-fluorouracil cream on precancerous skin spots can prevent skin cancer in people who are about to have an organ transplant. These patients are at a higher risk of developing skin cancer after their transplant due to the medications they take to prevent organ rejection. The treatment has shown promise in reducing skin cancer risk in people with healthy immune systems, and this study will see if it can help those who are immunosuppressed after a transplant.

Description

This clinical trial is testing a treatment that combines Calcipotriol ointment and 5-fluorouracil cream to see if it can prevent skin cancer in people who are about to receive an organ transplant. These patients often develop a type of skin cancer called squamous cell carcinoma (SCC) after their transplant because the medications they take to prevent organ rejection weaken their immune system. The treatment targets precancerous skin spots known as actinic keratoses (AKs), which can develop into SCC. Previous studies have shown that this combination treatment can significantly reduce the risk of SCC in people with healthy immune systems by boosting the body's immune response to these precancerous spots. The study will determine if this treatment is effective in organ transplant patients, despite their weakened immune systems.

Eligibility Criteria

Inclusion Criteria

  • Candidates for kidney, lung, liver, or heart transplants who have precancerous skin spots (AKs) and a history of non-melanoma skin cancer.
  • Have between four to fifteen visible AKs in a 25 cm2 area on the scalp, face, or arms.
  • The time between the first visit and the transplant must be at least 4 weeks and no more than 12 months.
  • Must be 18 years or older.
  • Must be willing to participate and provide informed consent.

Exclusion Criteria

  • Treatment area is too close to an unhealed wound or suspected skin cancer.
  • Treatment area has thickened or hard skin spots that haven't responded to freezing treatment.
  • History of high calcium levels or vitamin D toxicity.
  • Female participants must either be unable to have children or have a negative pregnancy test before joining the study.
  • Patients with a specific enzyme deficiency (DPD) that increases the risk of side effects from 5-FU.

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