Study on Using Immunotherapy After Transplant to Prevent Skin Cancer in Organ Transplant Recipients

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04642287

Provider View

This clinical trial is exploring whether a combination of Calcipotriol ointment and 5-FU cream can help organ transplant recipients prevent skin cancer by boosting their immune response against precancerous skin lesions.

Patient Parameters

Program Overview

The purpose of this study is to find out if using Calcipotriol ointment together with 5-FU cream can help organ transplant recipients (OTRs) prevent skin cancer. These patients are at a higher risk of developing skin cancer due to the medications they take to prevent organ rejection. The study aims to see if this treatment can stimulate the immune system to fight off precancerous skin lesions called actinic keratoses (AKs) and prevent the development of squamous cell carcinoma (SCC), a common type of skin cancer after transplantation.

Description

This study is testing a treatment that combines Calcipotriol ointment and 5-FU cream to see if it can help organ transplant recipients (OTRs) prevent skin cancer. OTRs are more likely to develop skin cancer because of the medications they take to prevent their body from rejecting the transplanted organ. These medications weaken the immune system, making it harder to fight off skin cancer.

The treatment being tested has shown promise in boosting the immune system's ability to fight off precancerous skin lesions called actinic keratoses (AKs) in people with healthy immune systems. The study will see if this treatment is also effective in OTRs who are on immunosuppressive medications. Calcipotriol is a vitamin D-based ointment approved for treating psoriasis, and 5-FU is a standard treatment for AKs. Together, they may help the immune system target and destroy early skin cancer cells.

The study will focus on whether this treatment can reduce the risk of developing squamous cell carcinoma (SCC), a common type of skin cancer in OTRs, and if it can help maintain a strong immune response against these precancerous lesions over the long term.

Eligibility Criteria

Inclusion Criteria

  • Must be an organ transplant recipient with a history of non-melanoma skin cancer in the past year.
  • Have between four to fifteen visible actinic keratoses (AKs) in a 25 cm2 area on the scalp, face, or arms.
  • The time between the first study visit and the transplant must be between 4 weeks and 12 months.
  • Must be at least 18 years old.
  • Must be willing and able to participate in the study, with informed consent provided.

Exclusion Criteria

  • Treatment area is too close to an unhealed wound or suspected skin cancer.
  • Treatment area has thickened or hard lesions that haven't responded to previous treatments.
  • 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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