An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell
carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and
protein levels in tumor biopsy samples, when compared to baseline levels.
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell
carcinoma in humans.
Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Percent decrease in GLI2 protein levels
Analyzed using nonparametric methods (Wilcoxon sign rank test).
From baseline to day 5 of course 2
United States: Institutional Review Board
|Stanford University||Stanford, California 94305|