Clinical trial NCT00003611: Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Official title: Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-melanomatous Skin Cancer
Keywords: basal cell carcinoma of the skin
squamous cell carcinoma of the skin
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: rate of new primary nonmelanoma skin cancers
timeFrame: Up to 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: CCOP - Scottsdale Oncology Program
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Peoria
country: United States
facility: CCOP - Illinois Oncology Research Association
state: Illinois
city: Urbana
country: United States
facility: CCOP - Carle Cancer Center
state: Illinois
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Health Plaza
state: Minnesota
city: Bismarck
country: United States
facility: Medcenter One Health System
state: North Dakota
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: Mark R. Pittelkow, MD
role: STUDY_CHAIR
References:
citation: Kadakia KC, Barton DL, Loprinzi CL, Sloan JA, Otley CC, Diekmann BB, Novotny PJ, Alberts SR, Limburg PJ, Pittelkow MR. Randomized controlled trial of acitretin versus placebo in patients at high-risk for basal cell or squamous cell carcinoma of the skin (North Central Cancer Treatment Group Study 969251). Cancer. 2012 Apr 15;118(8):2128-37. doi: 10.1002/cncr.26374. Epub 2011 Aug 31.