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CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA


Phase 2
18 Years
80 Years
Not Enrolling
Both
Lymphoma

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Trial Information

CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma

Outcome Time Frame:

3 Years

Safety Issue:

No

Principal Investigator

Gideon Steinbach, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CPPDM95-084

NCT ID:

NCT00002682

Start Date:

August 1995

Completion Date:

October 2001

Related Keywords:

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

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
MD Anderson Cancer Center Orlando Orlando, Florida  32806