A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Lovastatin for Various Endpoints of Melanoma Pathobiology

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])
=< 2.5 X within normal limits

- Creatinine within normal institutional limits

- Ability to understand and the willingness to sign the written informed consent

- Subjects willing and able to participate for the full duration of the study

- For women of child-bearing potential (women are considered not of childbearing
potential if they are at least 2 years post-menopausal and/or surgically sterile),
she:

- has been using adequate contraception (abstinence, intrauterine device [IUD],
birth control pills, or spermicidal gel with diaphragm or condom) since her last
menses and will use adequate contraception during the study

- is not lactating, and

- has had a documented negative serum pregnancy test within 30 days prior to the
first dose of study medication Should a woman become pregnant or suspect she is
pregnant while participating in this study, she will be taken off study and be
advised to inform her treating physician immediately; a telephone follow-up with
the subject post-delivery will be completed to obtain outcome of pregnancy

- Men partnered with a female of child-bearing age must agree to use adequate
contraception while on the study (i.e. abstinence, IUD, birth control pills, or
spermicidal gel with diaphragm or condom)

Exclusion Criteria:

- Subjects with untreated melanoma of any stage or locally advanced (>= 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