Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002682
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
1999-11-01
Brief Title:
Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
CURRENT PRACTICE STUDY OF ANTIBIOTIC TREATMENT OF GASTRIC MALT LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016672 | NIH | None | None |
| MDA-CPPDM-95084 | None | None | None |
| NCI-T95-0003D | None | None | None |
| CDR0000064361 | OTHER | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |