Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention Completed 18 and over NCI NCCTG-969251 NCI-P98-0137, NCT00003611

Objectives

1. 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.
2. Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of these patients.
3. 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.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Greater than 2 years

Hematopoietic:

• WBC at least 3400/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Mark Pittelkow, MD, Protocol chair		Ph: 507-284-7821 Email: pittelkow.mark@mayo.edu

Registry Information
Official Title		Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients with Multiple Prior Treated Skin Cancers
Trial Start Date		2000-05-26
Trial Completion Date		2003-02-21
Registered in ClinicalTrials.gov		NCT00003611
Date Submitted to PDQ		1998-10-02
Information Last Verified		2003-06-05
NCI Grant/Contract Number		CA31946

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