Clinical trial NCT00002682: Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Official title: CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: Antibiotic Treatment
Gastric Malt Lymphoma
stage I marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: MD Anderson Cancer Center Orlando
state: Florida
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gideon Steinbach, MD, PhD
role: STUDY_CHAIR
References: