Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002682

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 II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cancer Lymphoma

Drug Information available for: Tetracycline Tetracycline hydrochloride Dioctyl sulfosuccinic acid Bismuth subsalicylate Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Metronidazole hydrochloride Metronidazole phosphate Omeprazole Clarithromycin Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Docusate calcium Metronidazole Bismuth Kaopectate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	75
Study Start Date:	August 1995

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

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Gideon Steinbach, MD, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000064361, MDA-CPPDM-95084, NCI-T95-0003D
Study First Received:	November 1, 1999
Last Updated:	November 16, 2008
ClinicalTrials.gov Identifier:	NCT00002682 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Additional relevant MeSH terms:

Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Omeprazole
Lymphoma, B-Cell, Marginal Zone
Tetracycline
Lymphoma, B-Cell
Clarithromycin
Anti-Bacterial Agents
Antiparasitic Agents
Therapeutic Uses
Anti-Ulcer Agents
Lymphoma

Amoxicillin
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Bismuth subsalicylate
Pharmacologic Actions
Antidiarrheals
Lymphatic Diseases
Protein Synthesis Inhibitors
Neoplasms
Radiation-Sensitizing Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 08, 2010