Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
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.
Drug: Bismuth Subsalicylate
Drug: Metronidazole Hydrochloride
Drug: Tetracycline Hydrochloride
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA|
- Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
|Study Start Date:||August 1995|
|Study Completion Date:||October 2001|
|Primary Completion Date:||October 2001 (Final data collection date for primary outcome measure)|
|Experimental: Antibiotic Treatment||Drug: Amoxicillin Drug: Bismuth Subsalicylate Drug: Clarithromycin Drug: Metronidazole Hydrochloride Drug: Omeprazole Drug: Tetracycline Hydrochloride|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002682
|United States, Florida|
|MD Anderson Cancer Center Orlando|
|Orlando, Florida, United States, 32806|
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Gideon Steinbach, MD, PhD||M.D. Anderson Cancer Center|