Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Recurrent Skin Cancer Clinical Trial

— ATO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791894
• Other study ID #: IRB-26400
• Secondary ID: SKIN0015
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Basal Cell Carcinoma of the Skin
• Carcinoma
• Carcinoma, Basal Cell
• Recurrent Skin Cancer
• Skin Neoplasms

Intervention

Drug:
• arsenic trioxide
Given IV

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	The V Foundation for Cancer Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Biomarker (GLI2 Protein) Levels		baseline to day 33
Secondary	Patients With Stable Disease Post Treatment	Number of patients with stable disease post treatment by RECIST criteria	After 3 cycles of treatment (approx. 61 days)
Secondary	Patients With Progressive Disease Post Treatment by RECIST Criteria	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	After 3 treatment cycles (approx. 61 days)
Secondary	Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0		Baseline to cycle 3