Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by Stanford University.
Recruitment status was  Active, not recruiting
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University Identifier:
First received: February 12, 2013
Last updated: October 16, 2013
Last verified: October 2013
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 Intervention
Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer
Drug: arsenic trioxide
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percent decrease in GLI2 protein levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]
    Analyzed using nonparametric methods (Wilcoxon sign rank test).

Secondary Outcome Measures:
  • Change in tumor GLI1 protein or mRNA levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]
    Analyzed using Wilcoxon sign rank test.

  • Tumor size change in the longest diameter, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]
    Analyzed using Wilcoxon sign rank test.

  • Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) attributable to arsenic trioxide will be collected and tabulated for cumulative evaluation.

Estimated Enrollment: 5
Study Start Date: April 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other: laboratory biomarker analysis
Correlative studies

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01791894

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Principal Investigator: Jean Tang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University Identifier: NCT01791894     History of Changes
Other Study ID Numbers: SKIN0015, NCI-2013-00387
Study First Received: February 12, 2013
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial
Skin Diseases
Arsenic trioxide
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 30, 2015