Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · May 31, 2019
Trial Information
Current as of July 23, 2025
Unknown status
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About Hospital De Clinicas De Porto Alegre
Hospital de Clínicas de Porto Alegre (HCPA) is a leading academic medical center in Brazil, renowned for its commitment to advancing healthcare through innovative clinical research. As a sponsor of clinical trials, HCPA leverages its extensive expertise in various medical disciplines to conduct rigorous studies aimed at improving patient outcomes and contributing to the global medical community. With a multidisciplinary team of skilled professionals and state-of-the-art facilities, HCPA fosters a collaborative environment that prioritizes ethical standards, patient safety, and scientific integrity in all its research endeavors.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Porto Alegre, Rs, Brazil
Patients applied
Trial Officials
Renato M Bakos, Ph. D.
Study Chair
Hospital de Clinicas de Porto Alegre
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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