Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- clinical response
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Itraconazole
Oral Itraconazole capsules, 200 mg
Intervention: Itraconazole 200 mg (Drug)
Outcomes
Primary Outcomes
clinical response
Time Frame: 60 days
tumor area response registered through dermatologic evaluation
hedgehog pathway activity
Time Frame: 60 days
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
Secondary Outcomes
No secondary outcomes reported