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

Last updated: May 31, 2019
Sponsor: Hospital de Clinicas de Porto Alegre
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Warts

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT03972748
47011715.0.0000.5327
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologicallyconfirmed.

  • 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

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 andAST and ALT > than 5 x ULN.

  • Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measuredthrough 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 Design

Total Participants: 28
Study Start date:
January 05, 2018
Estimated Completion Date:
June 01, 2021

Study 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.

Connect with a study center

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RS 90035903
    Brazil

    Active - Recruiting

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