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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00002682
First received: November 1, 1999
Last updated: July 27, 2012
Last verified: July 2012

November 1, 1999
July 27, 2012
August 1995
October 2001   (final data collection date for primary outcome measure)
Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002682 on ClinicalTrials.gov Archive Site
Not Provided
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Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
  • Drug: Amoxicillin
  • Drug: Bismuth Subsalicylate
  • Drug: Clarithromycin
  • Drug: Metronidazole Hydrochloride
  • Drug: Omeprazole
  • Drug: Tetracycline Hydrochloride
Experimental: Antibiotic Treatment
Interventions:
  • Drug: Amoxicillin
  • Drug: Bismuth Subsalicylate
  • Drug: Clarithromycin
  • Drug: Metronidazole Hydrochloride
  • Drug: Omeprazole
  • Drug: Tetracycline Hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
October 2001
October 2001   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002682
CPPDM95-084, P30CA016672, MDA-CPPDM-95084, NCI-T95-0003D, CDR0000064361
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Gideon Steinbach, MD, PhD M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP