Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma
Recruitment status was Active, not recruiting
Basal Cell Carcinoma of the Skin
Recurrent Skin Cancer
Drug: arsenic trioxide
Other: laboratory biomarker analysis
|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 decrease in GLI2 protein levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]Analyzed using nonparametric methods (Wilcoxon sign rank test).
- Change in tumor GLI1 protein or mRNA levels [ Time Frame: From baseline to day 5 of course 2 ] [ Designated as safety issue: No ]Analyzed using Wilcoxon sign rank test.
- Tumor size change in the longest diameter, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From baseline to 1 year ] [ Designated as safety issue: No ]Analyzed using Wilcoxon sign rank test.
- Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria [ Time Frame: At 3 months ] [ Designated as safety issue: No ]
- Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Adverse events (AEs) attributable to arsenic trioxide will be collected and tabulated for cumulative evaluation.
|Study Start Date:||April 2013|
|Estimated Primary Completion Date:||June 2014 (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
Other Names:Other: laboratory biomarker analysis
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|