Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: Amoxicillin
Drug: Bismuth Subsalicylate
Drug: Clarithromycin
Drug: Metronidazole Hydrochloride
Drug: Omeprazole
Drug: Tetracycline Hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: August 1995
Study Completion Date: October 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic Treatment Drug: Amoxicillin Drug: Bismuth Subsalicylate Drug: Clarithromycin Drug: Metronidazole Hydrochloride Drug: Omeprazole Drug: Tetracycline Hydrochloride

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002682

Locations
United States, Florida
MD Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Gideon Steinbach, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00002682     History of Changes
Other Study ID Numbers: CPPDM95-084, P30CA016672, MDA-CPPDM-95084, NCI-T95-0003D, CDR0000064361
Study First Received: November 1, 1999
Last Updated: July 27, 2012
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Antibiotic Treatment
Gastric Malt Lymphoma
stage I marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Anti-Bacterial Agents
Antibiotics, Antitubercular
Bismuth subsalicylate
Clarithromycin
Metronidazole
Tetracycline
Anti-Infective Agents
Antidiarrheals
Antiparasitic Agents
Antiprotozoal Agents
Antitubercular Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014