Status:
COMPLETED
Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
Lead Sponsor:
Stanford University
Collaborating Sponsors:
The V Foundation for Cancer Research
Conditions:
Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 tu...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01791894
Start Date
April 1 2013
End Date
November 1 2015
Last Update
June 8 2018
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305