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

Early Phase 1UnknownNCT02749513

Dallas VA Medical Center18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

ItraconazoleDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dallas VA Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Inhibition of Hedgehog pathway signaling as measured by real-time PCR.

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.

Time frame: 2-3 weeks

Secondary Outcomes

Inhibition of VEGFR2 pathway signaling as measured by Western blot

Protein expression levels of phosphorylated VEGFR2 will be compared between baseline and post-itraconazole treatment.

Time frame: 2-3 weeks

Data from ClinicalTrials.gov

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