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

CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002682

Enrollment

Registered

2004-06-10

Start date

1995-08-10

Completion date

2001-10-08

Last updated

2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Antibiotic Treatment, Gastric Malt Lymphoma, stage I marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

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.

Interventions

DRUGAmoxicillin

DRUGBismuth Subsalicylate

DRUGClarithromycin

DRUGMetronidazole Hydrochloride

DRUGOmeprazole

DRUGTetracycline Hydrochloride

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: Suspected gastric lymphoma or documented gastric lymphoma of mucosa-associated lymphoid tissue (MALT) that is stage IE Gastric MALT lymphoma with perigastric lymph nodes identified on endoscopic ultrasound eligible at MDACC and Houston VA Medical Center only No indication for expeditious treatment with chemotherapy, radiotherapy, or surgery based on clinical condition, underlying illness, or tumor stage PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No contraindication to endoscopy or biopsy No pregnant or nursing women Adequate contraception required of fertile patients PRIOR CONCURRENT THERAPY: No concurrent chemotherapy or radiotherapy

Design outcomes

Primary

Measure	Time frame
Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma	3 Years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026