Clinical Trial: Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma

Brief Summary: This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating patients with basal cell cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Itraconazole may help treat fungal infections in patients with basal cell cancer. Giving arsenic trioxide with itraconazole may work better in treating basal cell cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To evaluate the response of arsenic trioxide/itraconazole in patients with refractory basal cell carcinoma.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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.


Sponsor: Jean Yuh Tang

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: March 1, 2016
Date Started: January 2017
Date Completion: November 2019
Last Updated: December 9, 2016
Last Verified: December 2016