Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer
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|ClinicalTrials.gov Identifier: NCT02699723|
Recruitment Status : Not yet recruiting
First Posted : March 4, 2016
Last Update Posted : April 26, 2019
|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)|
|Estimated Enrollment :||5 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 :||September 2019|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699723
|Contact: Irene Bailey-Healyemail@example.com|
|United States, California|
|Stanford Cancer Institute||Not yet recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Irene Bailey-Healy 408-892-7261 firstname.lastname@example.org|
|Principal Investigator: Jean Tang|
|Principal Investigator:||Jean Tang||Stanford Cancer Institute|