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

NCT00644384 | Completed DMC

• 4 other identifiers: CDR0000582327P30CA015083MC02C81153-98
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-melanomatous Skin Cancer

Keywords

basal cell carcinoma of the skin; squamous cell carcinoma of the skin

Outcome Measures

Primary Outcomes (1)

• Rate of new non-melanoma skin cancer development

Secondary Outcomes (3)

• Time to new non-melanoma skin cancer development

• Gene expression (RAR/RXR, Fos/Jun, and AP-1)

• HPV DNA detection, sequencing, and quantification

Interventions

acitretin DRUG

gene expression analysis GENETIC

northern blotting GENETIC

polymerase chain reaction GENETIC

protein expression analysis GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Acitretin; Gene Expression Profiling; Blotting, Northern; Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Terpenes; Pigments, Biological; Biological Factors; Genetic Techniques; Investigative Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Molecular Probe Techniques; Nucleic Acid Amplification Techniques

Study Officials

• Mark R. Pittelkow, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2008
• First Posted: March 26, 2008
• Study Start: February 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 16, 2011

Record last verified: 2011-05