Testing a Skin Cream Combination to Boost the Immune System Against Precancerous Skin Lesions in Organ Transplant Patients

Sponsor: University of Arizona

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05699603

Provider View

This study is testing a combination of two skin creams, calcipotriene and 5-fluorouracil, to see if they can help prevent skin cancer in organ transplant recipients with precancerous skin lesions. The creams work by activating the immune system to fight against cancer cells.

Patient Parameters

Program Overview

This study is exploring whether a combination of two topical treatments, calcipotriene (a form of vitamin D) and 5-fluorouracil (a chemotherapy agent), can help prevent skin cancer in organ transplant recipients who have precancerous skin lesions known as actinic keratoses (AK). These lesions can increase the risk of developing skin cancer, especially in people who have had an organ transplant. The treatment aims to activate immune cells in the skin to fight against cancer.

Description

The main goal of this study is to see if the combination of calcipotriene and 5-fluorouracil can increase certain immune cells in the skin after treatment. Researchers will compare the number of these immune cells before and after treatment to see if there is an increase.

Secondary goals include:

  • Checking if these immune cells remain in the skin six months after treatment.
  • Measuring the reduction in the number of precancerous lesions after treatment.
  • Assessing the redness and irritation of the skin after treatment.
  • Comparing the effectiveness of the treatment on different body areas like the arms, face, and scalp.
  • Ensuring the treatment is safe and well-tolerated.
  • Monitoring for any signs of organ rejection.

Exploratory goals include:

  • Checking for new skin cancers in treated areas six months after treatment.
  • Evaluating other immune responses in the skin after treatment.
  • Comparing immune responses in treated precancerous lesions versus normal skin.

Participants will apply the cream twice daily for six days and may undergo skin biopsies during the study. If precancerous lesions persist, a second course of treatment may be given.

Eligibility Criteria

Inclusion Criteria

  • Must have had a kidney or lung transplant at least 2 years ago and be in stable condition.
  • Have 4 to 15 visible precancerous skin lesions in a 25 cm² area on the arms, face, or scalp.
  • Be at least 18 years old.
  • Have a performance status of 60% or higher, meaning able to carry out most daily activities.
  • Have certain blood counts and organ functions within specified limits.
  • Women must be post-menopausal or have a negative pregnancy test and agree to use contraception during the study.
  • Must be willing and able to participate in the study.

Exclusion Criteria

  • Signs of organ rejection.
  • Recent cancer treatment or radiation within the past year.
  • Known deficiency in an enzyme that affects 5-FU metabolism.
  • History of high calcium levels or vitamin D toxicity.
  • Previous treatment with the study creams within the past year.
  • Treatment area too close to unhealed wounds or suspected skin cancer.
  • History of allergic reactions to similar medications.
  • Uncontrolled illnesses or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • HIV-positive individuals due to higher risks associated with their condition.
  • History of chronic hepatitis B or C.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.