Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation

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.

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