Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma (ATO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01791894
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : October 28, 2016
Last Update Posted : December 15, 2016
The V Foundation for Cancer Research
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma of the Skin Recurrent Skin Cancer Drug: arsenic trioxide Not Applicable

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arsenic
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (arsenic trioxide)
Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: arsenic trioxide
Given IV
Other Names:
  • Arsenic (III) Oxide
  • Arsenic Sesquioxide
  • Arsenous Acid Anhydride
  • AS2O3
  • Trisenox

Primary Outcome Measures :
  1. Percent Change in Biomarker (GLI2 Protein) Levels [ Time Frame: baseline to day 33 ]

Secondary Outcome Measures :
  1. Patients With Stable Disease Post Treatment [ Time Frame: After 3 cycles of treatment (approx. 61 days) ]
    Number of patients with stable disease post treatment by RECIST criteria

  2. Patients With Progressive Disease Post Treatment by RECIST Criteria [ Time Frame: After 3 treatment cycles (approx. 61 days) ]
    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

  3. 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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01791894

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The V Foundation for Cancer Research
Principal Investigator: Jean Tang Stanford University

Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University Identifier: NCT01791894     History of Changes
Other Study ID Numbers: SKIN0015
First Posted: February 15, 2013    Key Record Dates
Results First Posted: October 28, 2016
Last Update Posted: December 15, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be submitted to scientific journal for publication and shared at scientific meetings

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases
Arsenic trioxide
Antineoplastic Agents