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Sponsors and Collaborators: |
European Organization for Research and Treatment of Cancer University of Glasgow |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003151 |
RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.
PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Dietary Supplement: bismuth subcitrate Drug: amoxicillin Drug: clarithromycin Drug: metronidazole hydrochloride Drug: omeprazole Drug: tetracycline hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma |
Estimated Enrollment: | 96 |
Study Start Date: | September 1997 |
OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission rate after eradication of Helicobacter pylori in this patient population. III. Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.
OUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10.
Patients are evaluated at 8 weeks. Patients who experience complete remission and are H. pylori negative proceed to follow up. Patients with complete remission or no change but who are H. pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.
PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven, previously untreated, low grade gastric lymphoma Clinical stage I and II1 No bulky disease No high grade component (grade 5 and 4, if monoclonality proven, allowed) Documented presence/absence of H. pylori infection Measurable and/or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception No prior or concurrent malignancies unless: At least 1 year remission Low risk or recurrence No prior gastric malignancy No nonmalignant disease causing poor medical risk No allergy to omeprazole
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the abdomen Surgery: No prior gastric surgery except simple closure of perforated ulcer with or without wedge excision of the ulcer Other: No prior therapy for gastric lymphoma At least 30 days since experimental therapy No other concurrent experimental therapy At least 30 days since antibiotics with activity against H. pylori
United Kingdom, England | |
Charing Cross Hospital | |
London, England, United Kingdom, W6 8RF | |
Clatterbridge Centre for Oncology NHS Trust | |
Merseyside, England, United Kingdom, L63 4JY | |
Guy's, King's and St. Thomas' Hospitals Trust | |
London, England, United Kingdom, SE1 7EH | |
Hammersmith Hospital | |
London, England, United Kingdom, W12 ONN | |
Middlesex Hospital- Meyerstein Institute | |
London, England, United Kingdom, W1N 8AA | |
Royal Free Hospital School of Medicine | |
London, England, United Kingdom, NW3 2PF | |
Newcastle General Hospital | |
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE | |
Nottingham City Hospital NHS Trust | |
Nottingham, England, United Kingdom, NG5 1PB | |
Oxford Radcliffe Hospital | |
Oxford, England, United Kingdom, 0X3 7LJ | |
Royal Free Hospital | |
Hampstead, London, England, United Kingdom, NW3 2QG | |
Mount Vernon Hospital | |
Northwood, England, United Kingdom, HA6 2RN | |
Royal Marsden Hospital | |
Sutton, England, United Kingdom, SM2 5PT | |
Royal Marsden NHS Trust | |
London, England, United Kingdom, SW3 6JJ | |
Royal South Hants Hospital | |
Southampton, England, United Kingdom, SO14 0YG | |
Royal United Hospital | |
Bath, England, United Kingdom, BA1 3NG | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE | |
St. James's Hospital | |
Leeds, England, United Kingdom, LS9 7TF | |
University Birmingham N.H.S. Trust | |
Birmingham, England, United Kingdom, B15 2TA | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Beatson Oncology Centre | |
Glasgow, Scotland, United Kingdom, G11 6NT | |
Royal Infirmary | |
Glasgow, Scotland, United Kingdom, G4 0SF | |
Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 9NQ |
Study Chair: | Patrice P. Carde, MD | Institut Gustave Roussy |
Study Chair: | John W. Sweetenham, MD | University of Colorado at Denver and Health Sciences Center |
Study ID Numbers: | CDR0000065936, EORTC-20961, CRC-EORTC-20961, HOVON-33 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003151 History of Changes |
Health Authority: | United States: Federal Government |
contiguous stage II marginal zone lymphoma contiguous stage II small lymphocytic lymphoma stage I marginal zone lymphoma stage I small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Anti-Infective Agents Metronidazole Bismuth tripotassium dicitrate Amoxicillin Immunoproliferative Disorders Omeprazole Lymphoma, B-Cell, Marginal Zone Tetracycline Bismuth Lymphoma, B-Cell Clarithromycin |
Lymphatic Diseases Gastric Lymphoma Anti-Bacterial Agents Chronic Lymphocytic Leukemia Radiation-Sensitizing Agents B-cell Lymphomas Leukemia, Lymphocytic, Chronic, B-Cell Antacids Lymphoproliferative Disorders Leukemia, B-cell, Chronic Lymphoma |
Metronidazole Anti-Infective Agents Bismuth tripotassium dicitrate Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Omeprazole Tetracycline 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 Pharmacologic Actions Lymphatic Diseases Protein Synthesis Inhibitors Neoplasms Radiation-Sensitizing Agents Antacids Lymphoproliferative Disorders |