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

This study is no longer recruiting patients.

Sponsored by: North Central Cancer Treatment Group
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention
basal cell carcinoma of the skin
squamous cell carcinoma of the skin
 Drug: acitretin
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer

MedlinePlus related topics:  Skin Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Study of Acitretin in Patients with Multiple Prior Skin Cancers Who Received Solid Organ Transplantation

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

Performance status:

Life expectancy:

Hematopoietic:

Hepatic:

Renal:

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

Endocrine therapy:

Radiotherapy:

Surgery:

Other:


Location Information


Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States

Florida
      Mayo Clinic, Jacksonville,  Florida,  32224,  United States

Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States

      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States

Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

Minnesota
      CentraCare Health Plaza, Saint Cloud,  Minnesota,  56303,  United States

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States

South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States

      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Mark R. Pittelkow, MD,  Study Chair,  Mayo Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066688; NCCTG-969251; NCI-P98-0137
Record last reviewed:  June 2003
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003611
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-25
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