Topical Itraconazole in Treating Patients With Basal Cell Cancer

Study Overview
=================
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 Description
-----------------
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.

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

Conditions
-----------------
Skin Basal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Itraconazole
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form The subject must be willing to apply the medications twice daily for 1 month The subjects must have at least four BCCs in non-cosmetically sensitive sites For women of child-bearing potential, a negative urine pregnancy test Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose Exclusion Criteria: Pregnancy or breast-feeding History of congestive heart failure or other findings of ventricular dysfunction History of current evidence of malabsorption or liver disease Current immunosuppression or taking immunosuppressive drugs Taking oral itraconazole Taking any medication known to affect hedgehog (HH) signaling pathway The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (itraconazole and placebo)<br>Patients apply itraconazole topically BID and placebo topically BID for 12 weeks. | Drug: Itraconazole<br>* Applied topically<br>* Other names: Sporanox;Other: Placebo<br>* Applied topically<br>* Other names: sham therapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change of GLi levels in treated vs untreated tumors | will be assessed as relative GLi1 mRNA expression | Up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BCC tumor size | Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors [RECIST] criteria). | At baseline, 1, 4, and 12 weeks |