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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Applied topically
Applied topically
Stanford Cancer Institute
Palo Alto, California, United States
Percentage change of GLi levels in treated vs untreated tumors
will be assessed as relative GLi1 mRNA expression
Time frame: Up to 1 month
Change in BCC tumor size
Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria).
Time frame: At baseline, 1, 4, and 12 weeks
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