Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01791894
First received: February 12, 2013
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791894

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jean Tang Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov 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
Skin Neoplasms
Carcinoma, Basal Cell
Carcinoma, Basosquamous
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014