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 ]

will be assessed as relative GLi1 mRNA expression


Original Primary Outcome: Percentage change of biomarker levels in treated vs untreated tumors [ Time Frame: Up to 1 month ]

This will be tested by using a two sample t-test (Wilcoxan test), and the investigators will report the P value for the difference in the 2 groups


Current Secondary Outcome: Change in BCC tumor size [ Time Frame: At baseline, 1, 4, and 12 weeks ]

Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria).


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