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

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Acitretin

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