Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Non-melanomatous Skin Cancer
About this trial
This is an interventional prevention trial for Non-melanomatous Skin Cancer focused on measuring basal cell carcinoma of the skin, squamous cell carcinoma of the skin
Eligibility Criteria
DISEASE CHARACTERISTICS: Solid organ recipient (kidney, liver, heart, lung, or pancreas) receiving immunosuppressive agents (e.g., prednisone, other corticosteroid, azathioprine, cyclosporine, tacrolimus, mycophenolate mofetil) At least 6 months since transplant At least 2 prior (same event or separate events) basal cell carcinomas (BCC) or squamous cell carcinomas (SCC) resected All visible BCC and SCC resected PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: Greater than 2 years Hematopoietic: WBC at least 3400/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use two effective forms of birth control for at least 1 month before, during, and at least 3 years after study No history of oral retinoid intolerance No significant, uncontrolled hyperlipidemia No other significant medical condition or threatened allograft rejection state where retinoid use would be contraindicated PRIOR CONCURRENT THERAPY: Other: At least 1 year since prior retinoids No concurrent oral vitamin A supplements, topical retinoids, or other potentially irritating skin preparations No alcohol during and for 2 months after study
Sites / Locations
- CCOP - Scottsdale Oncology Program
- Mayo Clinic
- CCOP - Illinois Oncology Research Association
- CCOP - Carle Cancer Center
- CCOP - Iowa Oncology Research Association
- CCOP - Wichita
- Mayo Clinic Cancer Center
- CentraCare Health Plaza
- Medcenter One Health System
- Rapid City Regional Hospital
- CCOP - Sioux Community Cancer Consortium
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
acitretin
placebo
Patients receive oral acitretin daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.
Patients receive placebo daily for 2 years. Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies. Patients are followed every 6 months.