Overview

Itraconazole to Prevent Recurrent Barrett's Esophagus

Status:
Recruiting

Trial end date:
2023-12-01

Target enrollment:
0

Participant gender:
All

Summary

Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy. Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Kansas Medical Center

Collaborator:

University of Texas, Southwestern Medical Center at Dallas

Treatments:

Hydroxyitraconazole
Itraconazole

Criteria

Inclusion Criteria:

- Patients with Barrett's esophagus with either confirmed low-grade dysplasia or high
grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being
considered for endoscopic treatment. Patients must have an Eastern Cooperative
Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

- Inability to provide informed consent, New York Heart Association class III or IV
congestive heart failure (CHF), liver function tests (LFT)>3X upper limit of normal,
drug allergy to itraconazole, pregnancy, prolonged QTc (>450 ms for men and QTc>470 ms
for women) or critical drug interactions with other medications metabolized by
cytochrome P450(CYP)3A4.