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Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644384
First Posted: March 26, 2008
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of acitretin may stop cancer from growing in patients at high risk for basal cell carcinoma or squamous cell carcinoma of the skin.

PURPOSE: This randomized trial is studying how well acitretin works in preventing skin cancer in patients at high risk for skin cancer.


Condition Intervention
Non-melanomatous Skin Cancer Drug: acitretin Genetic: gene expression analysis Genetic: northern blotting Genetic: polymerase chain reaction Genetic: protein expression analysis Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Chemoprevention Trial of Acitretin Versus Placebo in Patients at High Risk for Basal Cell Carcinoma or Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Rate of new non-melanoma skin cancer development

Secondary Outcome Measures:
  • Time to new non-melanoma skin cancer development
  • Gene expression (RAR/RXR, Fos/Jun, and AP-1)
  • HPV DNA detection, sequencing, and quantification

Estimated Enrollment: 130
Study Start Date: February 2003
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the chemopreventive efficacy of acitretin, a synthetic retinoid, in patients at high risk for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
  • Evaluate human papillomavirus (HPV) as a possible etiologic cofactor in the development of cutaneous epidermal dysplasia/carcinoma from skin tissues of patients at high risk for BCC or SCC of the skin.
  • Determine the effect of acitretin on a series of potential surrogate endpoint biomarkers (SEBs), including specific retinoid receptors; the Fos/Jun family of proto-oncogenes and products; the Fos/Jun family of transcription factor complexes known as activating protein 1 (AP-1); and HPV DNA in normal (sun-protected), sun-exposed dysplastic and carcinoma (SCC/BCC) skin specimens.
  • Correlate standard clinical and histopathological dermatologic evaluation with modulation of SEBs.

OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs 50-59 years vs 60-69 years vs ≥ 70 years), number of skin cancers within the past 5 years (2-5 vs 6-10 vs 11-20 vs 21-30 vs > 30), most recent skin cancer occurrence (< 12 months ago vs ≥ 12 months ago), patient-reported sunburn susceptibility by Fitzpatrick skin type (1 vs 2 vs 3 vs 4 vs 5 vs 6), and assessment of visible skin damage (minimal vs moderate vs extensive). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral acitretin 5 days a week for 2 years in the absence of unacceptable toxicity.
  • Arm II: Patients receive oral placebo 5 days a week for 2 years in the absence of unacceptable toxicity.

Tissue samples of normal skin, excised squamous cell or basal cell carcinoma, or excised actinic keratoses are obtained at baseline and periodically during study. Tissue samples are analyzed for surrogate endpoint biomarkers, including RARγ, RXRα, Fos/Jun family of proto-oncogenes and products, AP-1 DNA binding activity, and presence, identification, and quantification of HPV DNA. mRNA and protein expression levels of RARγ, RXRα, and Fos/Jun family members are analyzed by northern blotting and/or quantitative polymerase chain reaction (PCR) methods. HPV is analyzed by PCR.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • At high risk for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, defined as a prior history of ≥ 3 nonmelanoma skin lesions

    • All visible BCC or SCC must have been resected prior to study entry

PATIENT CHARACTERISTICS:

  • Life expectancy > 5 years
  • Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
  • SGOT ≤ 2 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Cholesterol < 250 mg/dL
  • Triglycerides < 2.5 times ULN
  • Not pregnant
  • No history of significant, uncontrolled hyperlipidemia
  • No history of oral retinoid intolerance
  • No history of other significant medical condition that, in the opinion of the physician, would contraindicate retinoid use

PRIOR CONCURRENT THERAPY:

  • More than 1 year since prior retinoid therapy
  • At least 4 weeks since prior and no other concurrent use of oral vitamin A supplements, topical retinoids, or other potentially irritating skin preparations

    • Concurrent multivitamin supplements allowed
  • No prior organ transplantation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644384


Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark R. Pittelkow, MD Mayo Clinic
  More Information

Responsible Party: Mark R Pittelkow, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00644384     History of Changes
Other Study ID Numbers: CDR0000582327
P30CA015083 ( U.S. NIH Grant/Contract )
MC02C8 ( Other Identifier: Mayo Clinic Cancer Center )
1153-98 ( Other Identifier: Mayo Clinic IRB )
First Submitted: March 22, 2008
First Posted: March 26, 2008
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by Mayo Clinic:
basal cell carcinoma of the skin
squamous cell carcinoma of the skin

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Acitretin
Keratolytic Agents
Dermatologic Agents