Arsenic Trioxide in Treating Patients With Basal Cell Carcinoma (ATO)
|ClinicalTrials.gov Identifier: NCT01791894|
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : October 28, 2016
Last Update Posted : December 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma of the Skin Recurrent Skin Cancer||Drug: arsenic trioxide||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2015|
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
- Percent Change in Biomarker (GLI2 Protein) Levels [ Time Frame: baseline to day 33 ]
- Patients With Stable Disease Post Treatment [ Time Frame: After 3 cycles of treatment (approx. 61 days) ]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) ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791894
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jean Tang||Stanford University|