RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of acitretin may be an effective way to prevent the recurrence or further development of skin cancer.

PURPOSE: Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation.

Condition	Treatment or Intervention
basal cell carcinoma of the skin squamous cell carcinoma of the skin	Drug: acitretin  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer

Further Study Details: 

OBJECTIVES:

• 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 specimens.

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 studies.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 4-5 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Performance status:

• Not specified

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: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Mark R. Pittelkow, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000066688; NCCTG-969251; NCI-P98-0137
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003611
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08