Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Not Recruiting

Trial ID: NCT01791894


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

Official Title

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

Stanford Investigator(s)

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)



   - 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


   - 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


drug: arsenic trioxide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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