Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: Amoxicillin; Drug: Bismuth Subsalicylate; Drug: Clarithromycin; Drug: Metronidazole Hydrochloride; Drug: Omeprazole; Drug: Tetracycline Hydrochloride

• Registration Number: NCT00002682
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach.

PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.

Detailed Description

OBJECTIVES: I. Evaluate the response of gastric lymphoma of mucosa-associated lymphoid tissue (MALT) to treatment for Helicobacter pylori infection with antibiotics (amoxicillin, clarithromycin, tetracycline, and metronidazole) and with gastric acid inhibitors (omeprazole and bismuth subsalicylate). II. Correlate response with endoscopic tumor grade and clinical and pathological parameters. III. Assess the incidence of H. pylori infection in patients with gastric MALT lymphoma.

OUTLINE: All patients are treated on Regimen A; those receiving tetracycline on Regimen A are switched to Regimen B for their second course; those receiving amoxicillin for their first course receive tetracycline for their second course. Regimen A: Antibiotic Therapy with Gastric Acid Inhibition. Amoxicillin (or Tetracycline in penicillin-allergic patients); Clarithromycin; with Bismuth Subsalicylate; Omeprazole. Regimen B: Antibiotic Therapy with Gastric Acid Inhibition. Tetracycline; Metronidazole, METRO, NSC-50364; with Bismuth Subsalicylate; Omeprazole.

PROJECTED ACCRUAL: 75 patients will be entered over 3 years.

Study Timeline

• Study Start: 1995-08-10
• Study First Submitted: 1999-11-01
• Primary Completion: 2001-10-08
• Study Completion: 2001-10-08
• Study First Submitted QC: 2004-06-09
• Study First Posted: 2004-06-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antibiotic Treatment	Clarithromycin	-
Antibiotic Treatment	Amoxicillin	-
Antibiotic Treatment	Bismuth Subsalicylate	-
Antibiotic Treatment	Tetracycline Hydrochloride	-
Antibiotic Treatment	Metronidazole Hydrochloride	-
Antibiotic Treatment	Omeprazole	-

Primary Outcome Measures

Name	Time	Method
Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma	3 Years

Trial Locations

Locations (2)

University of Texas - MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

MD Anderson Cancer Center Orlando; 🇺🇸 Orlando, Florida, United States