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Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers


N/A
18 Years
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer

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Trial Information

Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Prevention

Principal Investigator

Mark R. Pittelkow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000066688

NCT ID:

NCT00003611

Start Date:

May 2000

Completion Date:

Related Keywords:

  • Non-melanomatous Skin Cancer
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • Skin Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Mayo ClinicJacksonville, Florida  32224
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303