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

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ClinicalTrials.gov Identifier: NCT03972748
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Hedgehog Pathway Drug: Itraconazole 200 mg Not Applicable

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Itraconazole
Oral Itraconazole capsules, 200 mg
 Drug: Itraconazole 200 mg
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.


Outcome Measures
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Primary Outcome Measures :
  1. clinical response [ Time Frame: 60 days ]
    tumor area response registered through dermatologic evaluation

  2. hedgehog pathway activity [ Time Frame: 60 days ]
    Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972748


Contacts
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Contact: Renato M Bakos, Ph. D. +555133598000 ext 8619 rbakos@hcpa.edu.br
Contact: Rodrigo P Pereira, M.D. +555133598000 ext 8619 rppereira@hcpa.edu.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035903
Contact: Renato M Bakos, Ph.D.    +555133598000 ext 8619    rbakos@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Study Chair: Renato M Bakos, Ph. D. Hospital de Clinicas de Porto Alegre
More Information
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03972748    
Other Study ID Numbers: 47011715.0.0000.5327
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital de Clinicas de Porto Alegre:
Itraconazole
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Basal Cell
Itraconazole
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Antifungal Agents
Anti-Infective Agents
 14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors