Arsenic Trioxide in Treating 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.

INCLUSION CRITERIA

- Basal cell carcinoma (BCC)

- Ineligible for curative locoregional treatment and have either progressed on, did not
tolerate, unwilling to try or ineligible for investigational smoothened antagonist
such as vismodegib (GDC 0449), XL 139 (BMS 833923), IPI- 926, LDE225 and PF-04449913

- Life expectancy estimate > 3 months

- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2

- Absolute neutrophil count ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Total bilirubin within normal institutional limits

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
≤ 2.5 x institutional upper limit of normal

- Creatinine within normal institutional limits

- Corrected QT interval (QTC) by 12 lead electrocardiogram (EKG) < 450 msecs

- Serum potassium within normal limits

- Magnesium within normal limits

- Calcium within normal limits

- Ability to understand and the willingness to sign a written informed consent document

- Evaluable tumor and be potentially eligible for pre and post ATO tumor biopsy

- Receiving potassium wasting diuretics or amphotericin, while not excluded, must be
noted to have theoretically increased arrhythmia risks with ATO

EXCLUSION CRITERIA

- Concurrent use of other Investigational agents

- Cardiac arrhythmias

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, recurrent seizure history or psychiatric illness/social situations that
would limit compliance with study requirements

- Pregnant or lactating