Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: amoxicillin (Drug); bismuth subcitrate (Drug); clarithromycin (Drug); metronidazole (Drug); omeprazole (Drug); tetracycline hydrochloride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: European Organization for Research and Treatment of Cancer Official(s) and/or principal investigator(s):
Patrice P. Carde, MD, Study Chair, Affiliation: Institut Gustave Roussy
John W. Sweetenham, MD, Study Chair, Affiliation: University of Colorado at Denver and Health Sciences Center
Summary
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.
Clinical Details
Official title: A Phase II Clinical Trial of Anti-Helicobacter Pylori Treatment in Endoscopically Diagnosed Low-Grade Localized Gastric Lymphoma
Study design: Treatment
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Charing Cross Hospital, London, England W6 8RF, United Kingdom
Clatterbridge Centre for Oncology NHS Trust, Merseyside, England L63 4JY, United Kingdom
Guy's, King's and St. Thomas' Hospitals Trust, London, England SE1 7EH, United Kingdom
Hammersmith Hospital, London, England W12 ONN, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England W1N 8AA, United Kingdom
Mount Vernon Hospital, Northwood, England HA6 2RN, United Kingdom
Newcastle General Hospital, Newcastle Upon Tyne, England NE4 6BE, United Kingdom
Nottingham City Hospital NHS Trust, Nottingham, England NG5 1PB, United Kingdom
Oxford Radcliffe Hospital, Oxford, England 0X3 7LJ, United Kingdom
Royal Free Hospital, Hampstead, London, England NW3 2QG, United Kingdom
Royal Free Hospital School of Medicine, London, England NW3 2PF, United Kingdom
Royal Marsden Hospital, Sutton, England SM2 5PT, United Kingdom
Royal Marsden NHS Trust, London, England SW3 6JJ, United Kingdom
Royal South Hants Hospital, Southampton, England SO14 0YG, United Kingdom
Royal United Hospital, Bath, England BA1 3NG, United Kingdom
Saint Bartholomew's Hospital, London, England EC1A 7BE, United Kingdom
St. James's Hospital, Leeds, England LS9 7TF, United Kingdom
University Birmingham N.H.S. Trust, Birmingham, England B15 2TA, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, Scotland AB25 2ZN, United Kingdom
Beatson Oncology Centre, Glasgow, Scotland G11 6NT, United Kingdom
Royal Infirmary, Glasgow, Scotland G4 0SF, United Kingdom
Western General Hospital, Edinburgh, Scotland EH4 9NQ, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 1997
Last updated: May 23, 2008
|
