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

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT03972748

Collaborator

(none)

Enrollment

Location

Arm

40.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jan 5, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jun 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.

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

clinical response [60 days]
tumor area response registered through dermatologic evaluation
hedgehog pathway activity [60 days]
Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS	Brazil	90035903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Investigators

Study Chair: Renato M Bakos, Ph. D., Hospital de Clinicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospital de Clinicas de Porto Alegre

ClinicalTrials.gov Identifier:

NCT03972748

Other Study ID Numbers:

47011715.0.0000.5327

First Posted:

Jun 4, 2019

Last Update Posted:

Jun 4, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital de Clinicas de Porto Alegre

Itraconazole

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Basal Cell

Itraconazole

Study Results

No Results Posted as of Jun 4, 2019