Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: The use of lovastatin may slow disease progression in patients at high risk of recurrent melanoma. It is not yet known whether lovastatin is more effective than a placebo in treating patients at high risk of recurrent melanoma.

PURPOSE: This randomized phase II trial is studying lovastatin to see how well it works compared to a placebo in treating patients at high risk of recurrent melanoma.

Further Study Information

OBJECTIVES:

Primary

• Compare histopathologic regression of atypical nevi in patients with atypical nevi and a history of primary melanoma receiving lovastatin vs placebo.

Secondary

• Compare clinical regression of atypical nevi in patients treated with these regimens.

• Compare changes in nevi numbers on the backs of patients treated with these regimens.

• Compare number of molecular biomarkers in patients treated with these regimens.

• Correlate serum markers known to be affected by lovastatin with the endpoints chosen above.

• Determine the safety and tolerability of these regimens in these patients.

OUTLINE: This is a randomized, placebo-controlled, double blind, multicenter study. Patients are stratified according to nevi status (two atypical nevi matched for atypia vs one large [≥ 8 mm diameter] nevus with one other atypical nevus). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral lovastatin once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive oral placebo once daily for up to 6 months in the absence of disease progression or unacceptable toxicity.

Biopsies and blood samples are collected periodically throughout study and are examined by histopathologic evaluation for molecular biomarker analysis, including VEGF, Ki-67, p21, and RelA.

After completion of study therapy, patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Meets any 1 of the following criteria:

• Presence of ≥ 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)

• No untreated melanoma of any stage or locally advanced (> 4 mm) or metastatic (stage III or IV) melanoma

• Patients with melanoma may be considered for this clinical trial after complete resection of stage I or II melanoma if they have declined or are ineligible to go on any available adjuvant clinical trials

• History of melanoma is not required for study entry

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%

• WBC ≥ 3,000/mm³

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Bilirubin normal

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine normal

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception prior to and during study

• No history of allergic reactions to compounds of similar chemical or biological composition to lovastatin

• No clinically significant unrelated systemic illness

• No medical or psychosocial condition that, in the opinion of the investigator, would limit study compliance

• No other malignancies within the past 5 years except for those meeting all of the following criteria:

• Currently without evidence of disease

• No treatment for invasive malignancy within the past 6 months

• No current or planned therapy

• Expected disease-free survival of ≥ 5 years

• No history of coronary artery disease or stroke

PRIOR CONCURRENT THERAPY:

• More than 3 months since prior and no concurrent adjuvant therapy or experimental therapy for melanoma

• More than 3 months since prior and no other concurrent lipid lowering agents of any type

• No chronic use of any of the following:

• Itraconazole

• Ketoconazole

• Erythromycin

• Clarithromycin

• Telithromycin

• HIV protease inhibitors

• Nefazodone

• Cyclosporine

• Gemfibrozil and other fibrates

• Danazol

• Amiodarone

• Verapamil

• Coumarin anticoagulants

• Niacin (nicotinic acid) > 1 g/day

• Large quantities of grapefruit juice (> 1 quart daily)

Trial Contact Information

Trial Lead Organizations/Sponsors

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Frank L. Meyskens

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00462280
Information obtained from ClinicalTrials.gov on December 14, 2011

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