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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| 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: | 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 |
| 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 |
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 |
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| 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 | |
| Study Chair: | Gideon Steinbach, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Gideon Steinbach, MD, PhD, UT MD 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: | May 13, 2010 |
| Health Authority: | United States: Federal Government |
|
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 Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Tetracycline Clarithromycin Amoxicillin Anti-Bacterial Agents Metronidazole |
Omeprazole Bismuth Bismuth subsalicylate Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antacids Antidiarrheals Gastrointestinal Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents |
