This phase II trial tests how well itraconazole works in combination with the usual standard of care endoscopy with ablation for the prevention of esophageal cancer in patients who have high-risk Barrett's esophagus (BE). BE is a condition in which the lining of the esophagus changes and becomes more like the tissue that lines the intestine. People with Barrett's esophagus have a higher risk of developing esophageal cancer. Itraconazole is a drug used to prevent or treat fungal infections. Ablation refers to the removal of abnormal tissue using heat. Endoscopy is a procedure for looking at the esophagus using a long, flexible tube called an endoscope, which has a video camera at the end. Radiofrequency ablation is a type of heat therapy that uses radiofrequency energy (similar to microwave heat) to destroy the abnormal tissue in the esophagus. Giving itraconazole in combination with standard of care endoscopy with ablation may improve the effects of ablation and prevent esophageal cancer in patients with high-risk Barrett's esophagus.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06732388.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Rogel Cancer CenterStatus: Active
Contact: David Wang
Phone: 734-232-4594
PRIMARY OBJECTIVE:
I. To evaluate if itraconazole in the peri-ablation period in participants with high-risk Barrett’s esophagus (BE) can accelerate BE regression i.e., achieve complete resolution of intestinal metaplasia (CRIM) faster than the control group.
SECONDARY OBJECTIVES:
I. To measure the time to event of complete eradication of dysplasia (CED).
II. To measure the rate of BE recurrence during routine follow-up.
III. To determine the safety and tolerability of itraconazole in participants with high-risk BE.
IV. To correlate levels of itraconazole and its primary metabolite hydroxyitraconazole in plasma and esophageal tissues with treatment response.
V. To compare biosocial impact on the participants in the itraconazole and control arms.
EXPLANATORY OBJECTIVE:
I. To correlate the degree of inhibition of Hedgehog (Hh), PI3K-AKT, and VEGFR2 signaling pathways with treatment response.
EXPLORATORY OBJECTIVES:
I. To determine whether expression (baseline and magnitude of change) of stem cell markers such as LGR5/CD44/DCAMKL1 can predict treatment response.
II. To bank blood samples and tissue biopsies for future analyses to understand the determinants of response.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive itraconazole orally (PO) twice daily (BID) on days 1-42 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles as long as there is an absence of disease progression or unacceptable toxicity. Patients undergo usual standard of care endoscopy and radiofrequency ablation on study. Patients also undergo blood sample collection throughout the study as well as tissue biopsy on study.
GROUP II: Patients receive placebo PO BID on days 1-42 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles as long as there is an absence of disease progression or unacceptable toxicity. Patients undergo usual standard of care endoscopy and radiofrequency ablation on study. Patients also undergo blood sample collection throughout the study as well as tissue biopsy on study.
After completion of study treatment, patients are followed up at 12 months.
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorAjay Bansal
