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	Treatment or Intervention	Phase
contiguous stage II diffuse small lymphocytic/marginal zone lymphoma stage I diffuse small lymphocytic/marginal zone lymphoma	Drug: amoxicillin  Drug: bismuth subcitrate  Drug: clarithromycin  Drug: metronidazole  Drug: omeprazole  Drug: tetracycline	Phase II

Further Study Details: 

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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY 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

--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

--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

United Kingdom, England
      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
United Kingdom, Scotland
      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

Study chairs or principal investigators

Patrice P. Carde,  Study Chair,  EORTC Lymphoma Cooperative Group   
J.W. Sweetenham,  Study Chair

Study ID Numbers:  CDR0000065936; EORTC-20961; HOVON-33
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003151
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08