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

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

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

Study Overview

• Status: Unknown
• Conditions: Basal Cell Carcinoma; Hedgehog Pathway
• Intervention / Treatment: Drug: Itraconazole 200 mg

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 Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035903
      • Recruiting
      • Hospital De Clinicas De Porto Alegre
      • Contact: Renato M Bakos, Ph.D.; Phone Number: 8619 +555133598000; Email: rbakos@hcpa.edu.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Itraconazole; Oral Itraconazole capsules, 200 mg	Drug: Itraconazole 200 mg; Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Study Chair: Renato M Bakos, Ph. D., Hospital De Clinicas De Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 31, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Itraconazole
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: 47011715.0.0000.5327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No