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

• ClinicalTrials.gov Identifier: NCT01791894
• Recruitment Status: Completed
• First Posted: February 15, 2013
• Results First Posted: October 28, 2016
• Last Update Posted: June 8, 2018
• Sponsor: Stanford University
• Collaborator: The V Foundation for Cancer Research
• Information provided by (Responsible Party): Jean Yuh Tang, Stanford University

Study Description

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	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: N/A
• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

INCLUSION CRITERIA

• 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

EXCLUSION CRITERIA

• 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

Contacts and Locations

Locations

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

The V Foundation for Cancer Research

Investigators

• Principal Investigator: Jean Tang, MD; Stanford University

More Information

• Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
• ClinicalTrials.gov Identifier: NCT01791894
• Other Study ID Numbers: IRB-26400; SKIN0015 ( Other Identifier: OnCore )
• First Posted: February 15, 2013
• Results First Posted: October 28, 2016
• Last Update Posted: June 8, 2018
• Last Verified: October 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Results will be submitted to scientific journal for publication and shared at scientific meetings

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Basal Cell; Skin Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Arsenic Trioxide; Antineoplastic Agents