A Phase II Double-Blind Study of Topical Tretinoin With or Without Oral 4-HPR (Fenretinide) in Patients With the Dysplastic Nevus Syndrome
OBJECTIVES: I. Compare the efficacy (clinical and histologic evidence of regression) of
topical tretinoin with or without systemic fenretinide in patients with dysplastic nevi with
personal or family history of cutaneous melanoma.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to
personal history of cutaneous melanoma vs family history of cutaneous melanoma in at least 2
blood relatives. Patients are randomized to one of two treatment arms. Arm I: Patients
receive topical tretinoin twice daily and oral fenretinide once a day for 6 months.
Tretinoin is applied to one half of the back with the untreated side of the back serving as
a matched control. Arm II: Patients receive topical tretinoin as in arm I twice daily and
oral placebo once a day for 6 months. Treatment continues in both arms in the absence of
disease progression or unacceptable toxicity. Patients are followed at 6 months.
PROJECTED ACCRUAL: There will be 38 patients accrued for this study.
Allocation: Randomized, Primary Purpose: Prevention
Lynn Mara Schuchter, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
|University of Pennsylvania Cancer Center
|Philadelphia, Pennsylvania 19104