We are interested in finding patients who have been diagnosed with Ménétrier's disease and wish to be treated with this new drug therapy.

QUALIFYING FOR THE CLINICAL TRIAL:

In order to qualify to participate in this trial, the patient must undergo a clinical evaluation by the Vanderbilt clinical trial team. This evaluation will include the following:

1. Screening: the study doctor will ask you questions about your health, medications you take for any health problems, and any surgical procedures you have had.

2. Upper endoscopy with biopsy and collection of gastric secretions: this involves looking at the inside of the stomach using a lighted tube that is inserted through the mouth. The biopsy procedure involves removing a tiny piece of stomach tissue to examine under the microscope. We will also collect a small amount of gastric secretions from your stomach.

3. Abdominal CT scan: this X-ray imaging technique measures the thickness of your stomach wall (if you have not already had this done).

4. Samples of blood and stool: these samples allow us to correlate stool alpha-1 antitrypsin with serum albumin levels. This tells us the amount of protein that is being lost from your body into your stomach. Blood will be drawn to test for a number of things, including the presence of antibodies to the experimental drug C225 in your system.

These procedures will be used to confirm a diagnosis of Ménétrier's disease, to determine your suitability for this study, and to obtain baseline parameters that we will follow during your treatment.


ELIGIBILTY REQUIREMENTS FOR THE TRIAL:

1. Patients must meet the clinical criteria of Ménétrier's disease.

2. Patients must be adults, 18 years to 80 years of age.


Who is NOT eligible to participate?

1. Children

2. Pregnant women or lactating mothers

3. Anyone who received previous therapy with C225 or another monoclonal antibody

4. Anyone who has a severe chronic disease which requires treatments that preclude the concurrent use of C225 or anyone who is medically unstable.

If you think you may not meet some of these criteria, but are interested in participating anyway, be sure to contact the clinical trial team to determine whether or not you can participate.

What does participation involve?

If you decide to participate in this trial, you will be required to receive your first treatments at Vanderbilt. If this represents a severe hardship, we may arrange treatment at one of our participating research centers. Your family doctor will not be able to administer these treatments to you.

If you participate in this trial, you will receive an infusion every week for 4 weeks of the medication, C225, used in this research. This will be called a course of therapy. Other medications will be administered with C225 treatment to reduce the likelihood of an allergic reaction to C225. If you have an improvement of symptoms, you may be eligible to receive additional courses of therapy if you do not have any serious side effects which require you to be removed from the study.

The method of administration of C225 is by IV, and an IV line will be placed in your arm for the administration of diphenhydramine (Benadryl) and C225. The infusion of the diphenhydramine (Benadryl) and the dose of C225 should take a total of two hours. We will also observe you for two more hours following treatment.

If you participate in the trial, you will receive the following evalutions during the study:

1. You will be asked to fill out a symptom questionnaire and quality-of-life questionnaire before the research study begins and at 4 weeks.

2. Blood collection (several tablespoons) and endoscopic examinations with biopsies of the lining of the stomach will be taken three times: during the pretreatment evaluation, twenty four hours after the first dose, and after the completion of the last treatment.

For the endoscopies, conscious sedation will be carried out using Versed (2-4 mg IV) which will reduce anxiety and minimize discomfort during the procedure. With this premedication, most patients do not even remember having undergone the procedure. A stool collection will be performed during the pretreatment evaluation and following the final treatment.

What will this treatment cost?

The drug, C225, will be provided by Imclone, free of charge. All study treatments will also be provided free of charge. Treatments unrelated to this trial which would be a normal part of your routine medical care for Ménétrier's disease are your (or your insurance company's or third party payer's) responsibility. There are no funds available to pay for parking expenses, transportation to and from the research center, lost time away from work and other activities, lost wages, or child care expenses. Lodging at the clinical study unit at Vanderbilt University Medical Center may be available.

What other treatment options are available?

Currently, Ménétrier's disease cannot be cured. Treatment involves relieving the symptoms, or in severe cases, removing all or part of the stomach. Though there is no cure, patients with Ménétrier's disease sometimes successfully alleviate their symptoms with such medications as H2 blockers (such as Pepcid) or proton pump inhibitors (such as Prilosec).

How can a patient sign up?

Contact Dr. Coffey to inquire about participation in this study.

Robert J. Coffey, MD
Vanderbilt University
Medical Research Building III, Suite 4140B
465 21st Avenue South
Nashville, Tennessee 37232-8355
615-936-3989

email: robert.coffey@Vanderbilt.edu

 


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