Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
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.
Non-melanomatous Skin Cancer
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Single Arm Open-Label Clinical Trial of Chemotherapy of BCC's With Tazarotene 0.1% in Subjects With Basal Cell Nevus Syndrome|
- Complete response rate [ Designated as safety issue: No ]
- Time to lesion clearance [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Estimated duration of complete response [ Designated as safety issue: No ]
- Overall response at treated lesions [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
- 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.
|United States, California|
|Children's Hospital and Research Center Oakland|
|Oakland, California, United States, 94609|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Ervin Epstein, MD||Children's Hospital & Research Center Oakland|
|Principal Investigator:||David R. Bickers, MD||Herbert Irving Comprehensive Cancer Center|