Trial Information

A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma

OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole,
colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade
gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission
rate after eradication of Helicobacter pylori in this patient population. III. Determine the
natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.

OUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral
omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10,
and oral metronidazole tid on days 4-10. Patients are evaluated at 8 weeks. Patients who
experience complete remission and are H. pylori negative proceed to follow up. Patients with
complete remission or no change but who are H. pylori positive proceed to a second course of
therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and
clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative
are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24
months, then annually thereafter.

PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.