Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer
|ClinicalTrials.gov Identifier: NCT02699723|
Recruitment Status : Withdrawn (Logistics)
First Posted : March 4, 2016
Last Update Posted : October 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Skin Basal Cell Carcinoma||Drug: Arsenic Trioxide Drug: Itraconazole Other: Laboratory Biomarker Analysis||Early Phase 1|
I. To evaluate the response of arsenic trioxide/itraconazole in patients with refractory basal cell carcinoma.
I. To determine if this treatment is associated with a reduction in Gli messenger ribonucleic acid (mRNA) levels in tumor and/or normal skin biopsy samples, when compared to baseline levels.
Patients receive arsenic trioxide orally (PO) and itraconazole PO daily for 50 days, followed by maintenance therapy consisting of 2 weeks off treatment and then 2 weeks on treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Treatment (arsenic trioxide, itraconazole)
Patients receive arsenic trioxide PO and itraconazole PO daily for 50 days, followed by maintenance therapy consisting of 2 weeks off treatment and then 2 weeks on treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.
Drug: Arsenic Trioxide
Other: Laboratory Biomarker Analysis
- Change in Gli levels [ Time Frame: Baseline to up to 1 month ]Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.
- Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria [ Time Frame: At 3 months ]Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699723
|Principal Investigator:||Jean Tang||Stanford Cancer Institute|