Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients

November 2, 2021 updated by: David Wang, Dallas VA Medical Center

Feasibility of Itraconazole as a Targeted Therapy for Inhibition of Hedgehog Pathway Signaling in Patients With Esophageal Cancer

The purpose of this study is to demonstrate that orally administered itraconazole, a commonly used antifungal medication, can inhibit Hedgehog pathway signaling in patients with esophageal cancer, including adenocarcinoma (EAC) and squamous cell carcinoma (ESCC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Clinical diagnosis of esophageal cancer, including gastroesophageal junction cancer

Exclusion Criteria:

  • Patients unwilling or unable to provide informed consent
  • Coagulopathy that precludes safe endoscopic/surgical procedure (platelet count <100,000/mm3, INR>1.5)
  • Esophageal varices
  • Comorbidity (e.g. pulmonary, cardiac, renal, or liver disease) that precludes safe participation in the study
  • QTc>450 ms
  • LFT's>3xULN
  • Pregnancy
  • Allergy to itraconazole
  • History of symptomatic congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Itraconazole
Itraconazole 300 mg po bid for 14-17 days
Drug: Itraconazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibition of Hedgehog pathway signaling as measured by real-time PCR.
Time Frame: 2-3 weeks
mRNA expression levels as measured by real-time PCR of Hedgehog pathway ligands and target genes will be compared between baseline and post-itraconazole treatment.
2-3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inhibition of VEGFR2 pathway signaling as measured by Western blot
Time Frame: 2-3 weeks
Protein expression levels of phosphorylated VEGFR2 will be compared between baseline and post-itraconazole treatment.
2-3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dallas VA Medical Center

Investigators

  • Principal Investigator: David Wang, MD, PhD, North Texas Veterans Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

September 1, 2019

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Actual)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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