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.

Condition	Treatment or Intervention	Phase
mucosa-associated lymphoid tissue stage I diffuse small lymphocytic/marginal zone lymphoma	Drug: amoxicillin  Drug: bismuth subsalicylate  Drug: clarithromycin  Drug: metronidazole  Drug: omeprazole  Drug: tetracycline	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   80 Years

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No concurrent chemotherapy or radiotherapy

--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

Florida
      MD Anderson Cancer Center Orlando, Orlando,  Florida,  32806,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Gideon Steinbach,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000064361; MDA-CPPDM-95084; NCI-T95-0003D
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002682
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08