Phase 2 N=5 Basic Science

Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma

Basal Cell Carcinoma of the Skin · Recurrent Skin Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01791894 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Oct 2016

Primary outcome: Primary: Percent Change in Biomarker (GLI2 Protein) Levels — 75 percentage decrease

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: arsenic trioxide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Nov 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Biomarker (GLI2 Protein) Levels	75	—
SECONDARY Patients With Stable Disease Post Treatment	3	—
SECONDARY Patients With Progressive Disease Post Treatment by RECIST Criteria	1	—
SECONDARY Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0	2	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01791894). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.