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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02749513
• Other study ID #: 15-084
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: January 2016
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Dallas VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: October 2022
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Itraconazole

Locations

Country	Name	City	State
United States	Dallas VA Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dallas VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Antonarakis ES, Heath EI, Smith DC, Rathkopf D, Blackford AL, Danila DC, King S, Frost A, Ajiboye AS, Zhao M, Mendonca J, Kachhap SK, Rudek MA, Carducci MA. Repurposing itraconazole as a treatment for advanced prostate cancer: a noncomparative randomized — View Citation

Kim DJ, Kim J, Spaunhurst K, Montoya J, Khodosh R, Chandra K, Fu T, Gilliam A, Molgo M, Beachy PA, Tang JY. Open-label, exploratory phase II trial of oral itraconazole for the treatment of basal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):745-51. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-3 weeks
Secondary	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.	2-3 weeks