NCT00002682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started Aug 1995

Typical duration for phase_2 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 1995

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

June 10, 2004

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

6.2 years

First QC Date

November 1, 1999

Last Update Submit

October 23, 2018

Conditions

Lymphoma

Keywords

Antibiotic TreatmentGastric Malt Lymphomastage I marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Response to Antibiotic Treatment of Gastric Malt Lymphoma

    3 Years

Study Arms (1)

Antibiotic Treatment

EXPERIMENTAL
Drug: AmoxicillinDrug: Bismuth SubsalicylateDrug: ClarithromycinDrug: Metronidazole HydrochlorideDrug: OmeprazoleDrug: Tetracycline Hydrochloride

Interventions

AmoxicillinDRUG
Antibiotic Treatment
Bismuth SubsalicylateDRUG
Antibiotic Treatment
ClarithromycinDRUG
Antibiotic Treatment
Metronidazole HydrochlorideDRUG
Antibiotic Treatment
OmeprazoleDRUG
Antibiotic Treatment
Tetracycline HydrochlorideDRUG
Antibiotic Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

MD Anderson Cancer Center Orlando

Orlando, Florida, 32806, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaLymphoma, B-Cell, Marginal Zone

Interventions

Amoxicillinbismuth subsalicylateClarithromycinMetronidazoleOmeprazoleTetracycline

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesBenzimidazolesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Gideon Steinbach, MD, PhD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

June 10, 2004

Study Start

August 10, 1995

Primary Completion

October 8, 2001

Study Completion

October 8, 2001

Last Updated

October 24, 2018

Record last verified: 2018-10

Locations

US(2)