Clinical Trial: Topical Itraconazole in Treating Patients With Basal Cell Cancer
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients
Brief Summary: This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
SECONDARY OBJECTIVES:
I. To determine if topical itraconazole gel will decrease BCC size.
OUTLINE:
Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
After completion of study treatment, patients are followed up for up to 14 weeks.
Sponsor: Jean Yuh Tang
Current Primary Outcome: Percentage change of GLi levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]
Original Primary Outcome: Percentage change of biomarker levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]
Current Secondary Outcome: Change in BCC tumor size [ Time Frame: At baseline, 1, 4, and 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: March 31, 2016
Date Started: March 2016
Date Completion: February 28, 2018
Last Updated: February 1, 2017
Last Verified: February 2017