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

Primary Purpose

Basal Cell Carcinoma, Hedgehog Pathway

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Itraconazole 200 mg

About this trial

This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Itraconazole

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Itraconazole

Arm Description

Oral Itraconazole capsules, 200 mg

Outcomes

Primary Outcome Measures

clinical response

tumor area response registered through dermatologic evaluation

hedgehog pathway activity

Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT03972748

First Posted

May 31, 2019

Last Updated

May 31, 2019

Sponsor

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT03972748

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 5, 2018 (Actual)

Primary Completion Date

December 1, 2020 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basal Cell Carcinoma, Hedgehog Pathway

Keywords

Itraconazole

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Itraconazole

Arm Type

Experimental

Arm Description

Oral Itraconazole capsules, 200 mg

Intervention Type

Drug

Intervention Name(s)

Itraconazole 200 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical response

Description

tumor area response registered through dermatologic evaluation

Time Frame

60 days

Title

hedgehog pathway activity

Description

Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.

Time Frame

60 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renato M Bakos, Ph. D.

Phone

+555133598000

Ext

8619

rbakos@hcpa.edu.br

First Name & Middle Initial & Last Name or Official Title & Degree

Rodrigo P Pereira, M.D.

Phone

+555133598000

Ext

8619

rppereira@hcpa.edu.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renato M Bakos, Ph. D.

Organizational Affiliation

Hospital de Clinicas de Porto Alegre

Official's Role

Study Chair

Facility Information:

Facility Name

Hospital de Clínicas de Porto Alegre

City

Porto Alegre

State/Province

ZIP/Postal Code

90035903

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renato M Bakos, Ph.D.

Phone

+555133598000

Ext

8619

rbakos@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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