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Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach

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ClinicalTrials.gov Identifier: NCT00002682
Recruitment Status : Completed
First Posted : June 10, 2004
Last Update Posted : October 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE June 10, 2004
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE August 10, 1995
Actual Primary Completion Date October 8, 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2010)
Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma [ Time Frame: 3 Years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00002682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Official Title  ICMJE CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Brief 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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: Amoxicillin
  • Drug: Bismuth Subsalicylate
  • Drug: Clarithromycin
  • Drug: Metronidazole Hydrochloride
  • Drug: Omeprazole
  • Drug: Tetracycline Hydrochloride
Study Arms  ICMJE Experimental: Antibiotic Treatment
Interventions:
  • Drug: Amoxicillin
  • Drug: Bismuth Subsalicylate
  • Drug: Clarithromycin
  • Drug: Metronidazole Hydrochloride
  • Drug: Omeprazole
  • Drug: Tetracycline Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2010)
5
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 8, 2001
Actual Primary Completion Date October 8, 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002682
Other Study ID Numbers  ICMJE CPPDM95-084
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-CPPDM-95084
NCI-T95-0003D
CDR0000064361 ( Other Identifier: NCI PDQ )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Gideon Steinbach, MD, PhD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP