Overview
Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
Status:
Unknown status
Unknown status
Trial end date:
2021-06-01
2021-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hospital de Clinicas de Porto AlegreTreatments:
Hydroxyitraconazole
Itraconazole
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.