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

NCT ID: NCT00002682

Last Updated: 2018-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-10

Study Completion Date

2001-10-08

Brief Summary

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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

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotic Treatment

Group Type EXPERIMENTAL

Amoxicillin

Intervention Type DRUG

Bismuth Subsalicylate

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Metronidazole Hydrochloride

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Tetracycline Hydrochloride

Intervention Type DRUG

Interventions

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Amoxicillin

Intervention Type DRUG

Bismuth Subsalicylate

Intervention Type DRUG

Clarithromycin

Intervention Type DRUG

Metronidazole Hydrochloride

Intervention Type DRUG

Omeprazole

Intervention Type DRUG

Tetracycline Hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gideon Steinbach, MD, PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDA-CPPDM-95084

Identifier Type: -

Identifier Source: secondary_id

NCI-T95-0003D

Identifier Type: -

Identifier Source: secondary_id

CDR0000064361

Identifier Type: OTHER

Identifier Source: secondary_id

CPPDM95-084

Identifier Type: -

Identifier Source: org_study_id

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