Status:
COMPLETED
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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. * Evalua...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2006
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00644384
Start Date
February 1 2003
End Date
May 1 2006
Last Update
May 16 2011
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