Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: amoxicillin (Drug); bismuth subsalicylate (Drug); clarithromycin (Drug); metronidazole (Drug); omeprazole (Drug); tetracycline hydrochloride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: M.D. Anderson Cancer Center
Official(s) and/or principal investigator(s):
Gideon Steinbach, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
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
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.
Official title: CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Study design: Treatment
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
PROJECTED ACCRUAL: 75 patients will be entered over 3 years.
Minimum age: 18 Years.
Maximum age: 80 Years.
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
PRIOR CONCURRENT THERAPY: No concurrent chemotherapy or radiotherapy
Locations and Contacts
MD Anderson Cancer Center Orlando, Orlando, Florida 32806, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1995
Last updated: May 23, 2008