Study on Itraconazole and Ablation to Prevent Esophageal Cancer in Patients with High-Risk Barrett's Esophagus

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06732388

Provider View

This clinical trial is testing whether the drug itraconazole, combined with a procedure called ablation, can help prevent esophageal cancer in patients with high-risk Barrett's esophagus. Barrett's esophagus is a condition where the lining of the esophagus changes, increasing the risk of cancer.

Patient Parameters

Program Overview

This study is exploring if using itraconazole, a medication typically used to treat fungal infections, along with a procedure called ablation, can help prevent esophageal cancer in people with high-risk Barrett's esophagus. Barrett's esophagus is a condition where the lining of the esophagus changes to resemble the intestine, which can increase the risk of developing esophageal cancer. Ablation is a treatment that uses heat to remove abnormal tissue. The study aims to see if combining itraconazole with standard ablation can improve the treatment's effectiveness in preventing cancer.

Description

The main goal of this study is to see if itraconazole can help speed up the healing process in patients with high-risk Barrett's esophagus when used around the time of ablation treatment. Researchers will also look at how long it takes for abnormal cells to be completely removed and how often Barrett's esophagus returns during follow-up. They will check the safety of itraconazole and how well patients tolerate it. The study will also explore how itraconazole levels in the blood and esophagus relate to treatment success.

Participants will be randomly assigned to one of two groups. One group will take itraconazole by mouth twice a day for six weeks, repeating this cycle up to two times if there are no serious side effects or disease progression. They will also undergo standard endoscopy and ablation procedures, along with blood tests and tissue biopsies. The other group will receive a placebo instead of itraconazole but will undergo the same procedures. After completing the study treatment, participants will have a follow-up visit at 12 months.

Eligibility Criteria

Inclusion Criteria

  • Adults with a history of Barrett's esophagus that is 2 cm or longer, with low-grade or high-grade dysplasia, or early-stage esophageal cancer, who have not yet received treatment and are being considered for ablation.
  • Diagnosis must be confirmed by two pathologists.
  • Participants must be 18 years or older.
  • Must be eligible for endoscopy and ablation treatment.
  • Must have adequate blood cell counts and liver function.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Patients with controlled hepatitis B or cured hepatitis C are eligible.
  • Women of childbearing potential must use effective birth control before, during, and after the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Severe heart failure (NYHA class III or IV).
  • Abnormal heart rhythm (prolonged QT interval).
  • Currently taking other experimental drugs.
  • Allergic to itraconazole or similar drugs.
  • Uncontrolled illness or psychiatric conditions that affect study participation.
  • Pregnant or breastfeeding women.
  • Taking medications that interact with itraconazole unless they can be safely managed.
  • History of eosinophilic esophagitis or strictures preventing ablation.
  • Active or recurrent cancer in other organs.
  • Esophageal cancer beyond early stage.

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