A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Lovastatin for Various Endpoints of Melanoma Pathobiology
I. To evaluate the primary endpoint of the trial, by analysis of histopathologic regression
of atypical nevi in response to a 6-month trial of oral (PO) lovastatin vs. placebo in
subjects with atypical nevi.
I. To evaluate clinical regression of atypical nevi in the lovastatin vs. placebo group.
II. To evaluate the secondary endpoint of changes in nevi numbers on subjects' backs in the
lovastatin vs. placebo groups.
III. To evaluate a number of molecular biomarkers as secondary endpoints in the lovastatin
vs. placebo groups.
IV. To evaluate the correlation of serum markers known to be affected by lovastatin with the
endpoints chosen above.
V. To evaluate the safety and tolerability of the dosing regimen, and the dose escalation.
OUTLINE: Patients are randomized into 1 of 2 treatment arms.
ARM I: Patients receive lovastatin PO once daily (QD) for up to 6 months in the absence of
disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO QD for up to 6 months in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Histopathologic regression of target atypical nevi with treatment
The level of atypia will be graded in a standard fashion which leads to seven levels of atypia, with zero being no atypia and six being a melanoma. The Wilcoxon rank sum test will be used to compare the changes from baseline in histopathologic score after treatment in both patient groups.
From baseline up to 24 weeks
Chao Family Comprehensive Cancer Center
United States: Institutional Review Board
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|University of California Medical Center At Irvine-Orange Campus||Orange, California 92868|