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

Basal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03972748
• Other study ID #: 47011715.0.0000.5327
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2018
• Est. completion date: June 1, 2021

Study information

• Verified date: May 2019
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Renato M Bakos, Ph. D.
• Phone: +555133598000
• Email: rbakos[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Hedgehog Pathway

Intervention

Drug:
• Itraconazole 200 mg
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response	tumor area response registered through dermatologic evaluation	60 days
Primary	hedgehog pathway activity	Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.	60 days