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

Hospital de Clinicas de Porto Alegre

Status

Unknown

Conditions

Hedgehog Pathway

Basal Cell Carcinoma

Treatments

Drug: Itraconazole 200 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03972748

47011715.0.0000.5327

Details and patient eligibility

About

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

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.