C225 (Cetuximab © ImClone Systems Inc.) is an anti-Epidermal Growth Factor Receptor monoclonal antibody (ImClone Systems). This antibody binds to EGFR on the surface of cells and prevents that receptor from receiving growth signals. We believe that too many of these signals in the stomachs of Ménétrier's disease patients causes the disease and that blocking them with C225 may be an effective treatment. This research is being done to develop the best possible care for future patients with Ménétrier's disease and to determine the toxicities and benefits of C225.

The use of C225 may cause side effects. It is not always possible to predict whether a particular person will suffer any side effects from using C225. Most problems stop when the use of the medication stops.

However, there is a possibility that some problems could remain for a long time or develop later. Information about known problems is based upon the experiences of over 600 men and women with cancer who have participated in past research using anti-epidermal growth factor receptor monoclonal antibody C225.

Skin

The most common C225-related adverse events were skin toxicities which included acne, rash, and swelling of the skin on the fingers (11%), mucositis (an inflammation or ulceration of the mucous membranes such as the nose and mouth) (2%), and allergic reactions (2%). The acne or rashes that occurred in patients treated with C225 generally occurred on the face, back, or upper chest, and were treated with topical or oral antibiotics, topical hydrocortisone, a modification of the amount of C225 taken, or a combination of all of these. These skin reactions tend to decrease with repeated drug administration and to resolve upon discontinuation of C225.

Allergic Reactions

Anaphylactic allergic reactions occurred in less than 2% of patients treated with C225. An anaphylactic reaction is an acute allergic reaction that includes constriction of the airways in the lungs which can prevent breathing and may lead to death. All of these patients who experienced anaphylactic reactions were given standard treatment for anaphylactic reactions, recovered completely, and were discontinued from the study. Severe or life-threatening allergic reactions, although rare, may occur. To help prevent an anaphylactic reaction, a small test dose of C225 is given before the total dose, and a doctor is standing by with the appropriate medications to treat an anaphylactic reaction in case one occurs. Anyone who experiences an anaphylactic reaction will be immediately discontinued from the trial.

Systemic Effects

In about 2% of the initial patients, some fatigue was noted.

Effects Observed in the Ménétrier's Disease Trial

Some patients treated with C225 for Ménétrier's disease developed an acne-like rash that improved when treated with topical antibiotics.

Another reaction that has been observed in this trial has been a sensation of warmth with the initial treatment.

Unknown Side Effects & Interactions

As with any new drug, new and unpredicted side effects may occur with the use of C225. We would be happy to provide information about C225. Other information on C225 (Cetuximab) is available in peer-reviewed medical literature, and from the manufacturer, ImClone Systems.

 


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