Lovastatin in Treating Patients At High Risk of Melanoma
Condition: Precancerous Condition; Stage 0 Melanoma; Stage I Melanoma; Stage II Melanoma
MeSH terms: Melanoma; Precancerous Conditions
Intervention: lovastatin; placebo; biopsy; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Correlative studies; Correlative studies
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The use of lovastatin may slow disease progression in patients at high risk of melanoma. It
      is not yet known whether lovastatin is more effective than a placebo in treating patients at
      high risk of melanoma. This randomized phase II trial studies how well giving lovastatin or
      placebo works in treating patients at high risk of melanoma.
    

Eligibility criteria:

        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