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

Not Applicable

• Conditions: Basal Cell Carcinoma; Hedgehog Pathway
• Interventions: Drug: Itraconazole 200 mg

• Registration Number: NCT03972748
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 Timeline

• Study Start: 2018-01-05
• Status Verified: 2019-05
• Study First Submitted: 2019-05-31
• Study First Submitted QC: 2019-05-31
• Last Update Submitted: 2019-05-31
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Primary Completion: 2020-12-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Itraconazole	Itraconazole 200 mg	Oral Itraconazole capsules, 200 mg

Primary Outcome Measures

Name	Time	Method
clinical response	60 days	tumor area response registered through dermatologic evaluation
hedgehog pathway activity	60 days	Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil