Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma (ATO)
Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer
Drug: arsenic trioxide
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open-label, Biomarker Study of Arsenic Trioxide for the Treatment of Patients With Basal Cell Carcinoma|
- Percent Change in Biomarker (GLI2 Protein) Levels [ Time Frame: baseline to day 33 ] [ Designated as safety issue: No ]
- Patients With Stable Disease Post Treatment [ Time Frame: After 3 cycles of treatment (approx. 61 days) ] [ Designated as safety issue: No ]Number of patients with stable disease post treatment by RECIST criteria
- Patients With Progressive Disease Post Treatment by RECIST Criteria [ Time Frame: After 3 treatment cycles (approx. 61 days) ] [ Designated as safety issue: No ]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
- Incidence of Grade 3/4 Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Baseline to cycle 3 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (arsenic trioxide)
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
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.
I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01791894
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jean Tang||Stanford University|