Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
- Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ
transplant recipients with a history of multiple previous basal cell carcinoma (BCC) or
squamous cell carcinoma (SCC) skin cancer resections.
- Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development
of cutaneous epidermal dysplasia/carcinoma from skin tissues of these patients.
- Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV
DNA in normal (sun protected), sun-exposed, and dysplastic and carcinoma (SCC/BCC) skin
OUTLINE: This is a randomized study. Patients are stratified according to age (at least 18
to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over), number of prior skin cancers in past 5
years (2 vs 3 vs at least 4), time since most recent skin cancer occurrence (less than 12
months vs at least 12 months), sunburn susceptibility (none vs moderate vs high), visible
skin damage (mild vs moderate vs severe).
Patients receive either oral acitretin or placebo daily for 2 years. Skin biopsies are
obtained at 1 year from normal areas and from any areas with skin cancer for genetic
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 4-5 years.
Allocation: Randomized, Primary Purpose: Prevention
Mark R. Pittelkow, MD
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|Mayo Clinic||Jacksonville, Florida 32224|
|Medcenter One Health System||Bismarck, North Dakota 58501|
|CentraCare Health Plaza||Saint Cloud, Minnesota 56303|