Clinical trial NCT01791894: Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
Official title: An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The V Foundation for Cancer Research
First posted: 2013-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Percent Change in Biomarker (GLI2 Protein) Levels
timeFrame: baseline to day 33
Secondary outcomes:
measure: Patients With Stable Disease Post Treatment
timeFrame: After 3 cycles of treatment (approx. 61 days)
measure: Patients With Progressive Disease Post Treatment by RECIST Criteria
timeFrame: After 3 treatment cycles (approx. 61 days)
measure: Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
timeFrame: Baseline to cycle 3
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Jean Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: