Itraconazole as a Targeted Therapy for Inhibiting Hedgehog Pathway Signaling in Esophageal Cancer Patients
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Itraconazole Itraconazole 300 mg po bid for 14-17 days |
Drug: Itraconazole
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dallas VA Medical Center | Dallas | Texas | United States | 75216 |
Sponsors and Collaborators
- Dallas VA Medical Center
Investigators
- Principal Investigator: David Wang, MD, PhD, North Texas Veterans Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-084