Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: Amoxicillin (Drug); Bismuth Subsalicylate (Drug); Clarithromycin (Drug); Metronidazole Hydrochloride (Drug); Omeprazole (Drug); Tetracycline Hydrochloride (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s): Gideon Steinbach, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
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.
Clinical Details
Official title: CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
MD Anderson Cancer Center Orlando, Orlando, Florida 32806, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database UT MD Anderson Cancer Center website
Starting date: August 1995
Last updated: July 27, 2012
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