| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-GI-0602 | |||
| VU-VICC-IRB-000851 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer.
OBJECTIVES:
OUTLINE: This is a non-randomized study.
Patients receive cetuximab IV on days 1, 8, 15, and 22. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete a quality of life questionnaire at baseline and during week 4.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab | Experimental | Cetuximab lV weekly at an initial loading dose of 400 ml/m2, followed by three weekly maintenance doses of 250 mg/m2. Four infusions of C225 will be defined as a course of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Response | 4 weeks |
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DISEASE CHARACTERISTICS:
Histologically confirmed Ménétrier disease
Symptomatic disease, including gastrointestinal symptoms which interfere with daily life
Must have failed medical therapy that was given for 6 months
No Helicobacter pylori infection
PATIENT CHARACTERISTICS:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No NYHA class III-IV cardiovascular disease
No clinically unstable pulmonary disease
No chronic disease requiring ongoing therapy for stabilization, including any of the following:
No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding disorders) that require medical management
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Robert J. Coffey, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D011230 | Precancerous Conditions |
| D005758 | Gastritis, Hypertrophic |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nashville |
| Tennessee |
| 37064 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D005756 | Gastritis |
| D005759 | Gastroenteritis |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |