Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.

Study Overview
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Brief Summary
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Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg twice daily, for 60 days, prior to curative intent surgery.

Detailed Description
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Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent. Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period. The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.

Official Title
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Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.

Conditions
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Basal Cell Carcinoma, Hedgehog Pathway

Intervention / Treatment
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* Drug: Itraconazole 200 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologically confirmed. At least one BCC lesion with 10 mm in the longest diameter Disease amenable to surgical intervention with curable intent. Signed Informed Consent PS ECOG 0 to 3 Exclusion Criteria: Chronic renal disease, with a glomerular filtration rate of less than 30 ml/min Acute or chronic liver disease, as measured by: total bilirubin > than 1.5 x ULN and AST and ALT > than 5 x ULN. Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography, Other active malignancies in the last year. Uncontrolled systemic hypertension, Any chronic infections such as tuberculosis, viral hepatitis and HIV. Pregnancy, suspected or confirmed. Known intolerance to the use of Itraconazole.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Itraconazole<br>Oral Itraconazole capsules, 200 mg | Drug: Itraconazole 200 mg<br>* Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical response | tumor area response registered through dermatologic evaluation | 60 days | 
| hedgehog pathway activity | Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment. | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Itraconazole