Non-melanomatous Skin Cancer Clinical Trial
Official title:
Phase IIB Randomized, Double-Blinded, Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine (DFMO) With and Without a Topical Corticosteroid Cream (Triamcinolone 0.1%) in the Therapy of Actinic Keratoses (AK) on the Forearms
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. Eflornithine with or without triamcinolone may be
effective in preventing nonmelanoma skin cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of eflornithine with or
without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic
keratosis.
OBJECTIVES: I. Compare the safety and efficacy of eflornithine (DFMO) vs placebo as
chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic
keratosis (AK). II. Determine whether this drug reverses AK in these patients. III. Determine
whether triamcinolone reduces DFMO-induced skin irritation in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
randomized to 1 of 4 treatment arms. Arm I: Patients receive eflornithine (DFMO) topically
and triamcinolone topically to forearms once daily. Arm II: Patients receive DFMO and placebo
topically as in arm I. Arm III: Patients receive placebo and triamcinolone topically as in
arm I. Arm IV: Patients receive 2 placebos topically as in arm I. Treatment continues for 6
months in the absence of unacceptable toxicity. Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 1 year.
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