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出境医 / 临床实验 / Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.

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

Study Description
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
Layout table for study information
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
Arms and Interventions
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
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

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
Layout table for investigator information
Study Chair: Renato M Bakos, Ph. D. Hospital de Clinicas de Porto Alegre
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE January 5, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2019)
  • clinical response [ Time Frame: 60 days ]
    tumor area response registered through dermatologic evaluation
  • hedgehog pathway activity [ Time Frame: 60 days ]
    Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
Official Title  ICMJE Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Basal Cell Carcinoma
  • Hedgehog Pathway
Intervention  ICMJE Drug: Itraconazole 200 mg
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.
Study Arms  ICMJE Experimental: Itraconazole
Oral Itraconazole capsules, 200 mg
Intervention: Drug: Itraconazole 200 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 31, 2019) 		28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03972748
Other Study ID Numbers  ICMJE 47011715.0.0000.5327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Hospital de Clinicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Renato M Bakos, Ph. D. Hospital de Clinicas de Porto Alegre
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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