Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Study Overview
=================
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

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.

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

Conditions
-----------------
Basal Cell Carcinoma of the Skin, Recurrent Skin Cancer

Intervention / Treatment
-----------------
* Drug: arsenic trioxide


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (arsenic trioxide)<br>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<br>* Given IV<br>* Other names: Trisenox;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Biomarker (GLI2 Protein) Levels |  | baseline to day 33 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 |  | Baseline to cycle 3 |