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

Skin Basal Cell Carcinoma Clinical Trial

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

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Skin Basal Cell Carcinoma

• NCT number: NCT02699723
• Study type: Interventional
• Source: Stanford University
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: December 2020
• Completion date: September 2021