Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 80	NCI	MDA-CPPDM-95084 NCI-T95-0003D, NCT00002682, T95-0003

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.

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

Expected Enrollment

75 patients will be entered over 3 years.

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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Gideon Steinbach, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 713-745-8548; 800-392-1611

Registry Information
Official Title		CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Trial Start Date		1995-08-10
Registered in ClinicalTrials.gov		NCT00002682
Date Submitted to PDQ		1995-08-10
Information Last Verified		2000-11-01