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

• Status: Active, not recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dallas VA Medical Center
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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