Conditions: Skin Carcinoma
Keywords: nevoid basal cell carcinoma syndrome basal cell carcinoma of the skin
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: no

Brief summary:
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 randomized phase II trial is comparing two different schedules of topical tazarotene and topical placebo to see how well they work in treating patients with basal cell skin cancer and basal cell nevus syndrome on the chest.

Detailed description:
OBJECTIVES:

Primary

* To expand and refine chemopreventive strategies in individuals with basal cell nevus syndrome (BCNS) on the chest and back, who are at high risk for the development of basal cell carcinomas (BCCs).
* To determine whether tazarotene 0.1% cream applied to the chest for two years will reduce the numbers of basal cell carcinomas (BCCs) observed, as compared to the number expected, based on changes in BCC numbers observed during months 0-12.

Secondary

* To compare the difference in total BCC burden (measured as the total lesion surface area) between chest and back over various time points and aggregated intervals of interest.
* To determine whether there are any detectable wash-in or wash-out periods for the tazarotene effects.
* Explore the use of a random effects model for longitudinal analysis of total lesions over time.

OUTLINE: This is a multicenter study. Patients are randomized into 1 of 2 arms.

* Arm I: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients apply vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest in the absence of disease progression or unacceptable toxicity.

Treated chest and untreated back is evaluated at 3 month intervals for 36 months.

Arms:
arm 1: Patients apply 0.1% tazarotene cream on months 0-12 and vehicle (placebo) on months 13-36 once daily to the chest. arm 2: Patients apply, vehicle (placebo) on months 0-12 and 0.1% tazarotene cream on months 13-36 once daily to the chest.

Interventions: intervention 1: tazarotene intervention 2: placebo
Intervention descriptions: intervention 1: Applied to the skin intervention 2: Applied to the skin

Protocol document: