This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
5
Given IV
Stanford University Medical Center
Stanford, California, United States
Percent Change in Biomarker (GLI2 Protein) Levels
Time frame: baseline to day 33
Patients With Stable Disease Post Treatment
Number of patients with stable disease post treatment by RECIST criteria
Time frame: After 3 cycles of treatment (approx. 61 days)
Patients With Progressive Disease Post Treatment by RECIST Criteria
Patients with a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time frame: After 3 treatment cycles (approx. 61 days)
Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Time frame: Baseline to cycle 3
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