Chemoprevention of Skin Cancers With DFMO: A Controlled, Randomized Clinical Trial
OBJECTIVES: I. Compare the rate of new skin cancer in patients with previously treated stage
0, I, or II basal or squamous cell skin cancer treated with eflornithine (DFMO) vs placebo.
II. Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as
an intermediary marker for response to DFMO in these patients. III. Determine whether
inhibition of skin polyamine levels serves as an intermediary marker for response to DFMO in
these patients. IV. Assess the long term toxic effects of this treatment in these patients.
OUTLINE: This a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral placebo daily for the first 4 weeks. Patients who comply with taking 80-100% of
placebo are randomized to one of two treatment arms. Arm I: Patients receive oral
eflornithine (DFMO) daily. Arm II: Patients receive an oral placebo daily. Treatment
continues for 3-5 years in the absence of unacceptable toxicity. Patients who develop skin
cancer during study undergo surgical excision and continue treatment on the arm to which
they were originally randomized. Patients are followed every 6 months through year 5.
PROJECTED ACCRUAL: A total of 334 patients (167 per arm) will be accrued for this study over
Allocation: Randomized, Primary Purpose: Prevention
Paul P. Carbone, MD
University of Wisconsin, Madison
United States: Federal Government