Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients
- Registration Number
- NCT02749513
- Lead Sponsor
- Dallas VA Medical Center
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 18
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Itraconazole Itraconazole Itraconazole 300 mg po bid for 14-17 days
- Primary Outcome Measures
Name Time Method Inhibition of Hedgehog pathway signaling as measured by real-time PCR. 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.
- Secondary Outcome Measures
Name Time Method Inhibition of VEGFR2 pathway signaling as measured by Western blot 2-3 weeks Protein expression levels of phosphorylated VEGFR2 will be compared between baseline and post-itraconazole treatment.
Trial Locations
- Locations (1)
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States