RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
OBJECTIVES: * Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS). * Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs. OUTLINE: This is an open-label, multicenter study. Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Tazarotene is a member of the acetylenic class of retinoids.
Children's Hospital and Research Center Oakland
Oakland, California, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York, New York, United States
Complete Response Rate
The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.
Time frame: 36 months
Time to Lesion Clearance
Time frame: 36 months
Time to Progression
Time frame: 36 months
Estimated Duration of Complete Response
Time frame: 36 months
Overall Response at Treated Lesions
Time frame: 36 months
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