Lovastatin in Treating Patients At High Risk of Melanoma

Inclusion Criteria

• Presence of at least 2 clinically atypical nevi on the body that are reasonably matched in regards to level of clinical atypia, or one atypical mole and another atypical mole >= 8 mm in diameter (for this pair the two moles do not have to be closely matched and only one of them must be >= 8 mm in diameter)
• A history of melanoma is not required for study entry
• Patients with completely resected stage I or II who have not received adjuvant therapy in the past 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better (Karnofsky > 70%)
• Leukocytes >= 3,000/uL
• Absolute neutrophil count >= 1,500/uL
• Platelets >= 100,000/uL
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) = = 4 mm in Breslow's thickness) or metastatic (stage III or IV) melanoma; subjects with melanoma may be considered for trial after complete resection of Stage I or II melanoma and those who have declined or are ineligible to go on any available adjuvant clinical trials known to the investigators or the subjects are eligible
• Subjects who are on adjuvant therapy or experimental therapy for melanoma currently or within the last 3 months prior to enrollment into this study
• Subjects currently or within the last three months before enrollment on lipid lowering agents of any type
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to lovastatin
• Clinically significant unrelated systemic illness
• Subjects with any medical or psychosocial condition that, in the opinion of the investigator, could jeopardize his/her participation in and compliance with the study
• Subjects may not be receiving any other investigational agents
• Pregnant or breast feeding females, or females of child bearing age not using a reliable method of contraception (use of lovastatin is contraindicated in pregnancy)
• Subjects who have been diagnosed with malignancies other than cutaneous melanoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma within 5 years of study entry, unless they:
• are currently without evidence of disease
• have not received treatment for invasive malignancy in the last 6 months
• have no current or planned therapy, and
• have an expected disease-free survival of at least 5 years from study entry
• Chronic use of: itraconazole; ketoconazole; erythromycin; clarithromycin; telithromycin; human immunodeficiency virus (HIV) protease inhibitors; nefazodone; cyclosporine; gemfibrozil and other fibrates; danazol; amiodarone (amiodarone hydrochloride); verapamil; coumarin anticoagulants; niacin (nicotinic acid) (>= 1 g/day); or large quantities of grapefruit juice (> l quart daily)
• Subjects with a history of coronary artery disease or stroke