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An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma

18 Years
Open (Enrolling)
Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer

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Trial Information

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.

Inclusion Criteria:

- Patients with basal cell carcinoma (BCC)

- Patients 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

- 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

- Include the following: ability to understand and the willingness to sign a written
informed consent document

- Patients must have evaluable tumor and be potentially eligible for pre and post ATO
tumor biopsy

Exclusion Criteria:

- Concurrent use of other Investigational agents is prohibited

- Patients with cardiac arrhythmias are excluded

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

- 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 women and breastfeeding women are excluded from this study

Type of Study:


Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Percent decrease in GLI2 protein levels

Outcome Description:

Analyzed using nonparametric methods (Wilcoxon sign rank test).

Outcome Time Frame:

From baseline to day 5 of course 2

Safety Issue:


Principal Investigator

Jean Tang

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Basal Cell Carcinoma of the Skin
  • Recurrent Skin Cancer
  • Carcinoma
  • Skin Neoplasms
  • Carcinoma, Basal Cell
  • Carcinoma, Basosquamous
  • Carcinoma, Squamous Cell



Stanford UniversityStanford, California  94305