An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell
carcinoma in humans.
OUTLINE:
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.
Interventional
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
No
Jean Tang
Principal Investigator
Stanford University
United States: Institutional Review Board
SKIN0015
NCT01791894
April 2013
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |