Protocol Number: 04-I-0176

Title:

Pilot Study of Omalizumab in Eosinophilic Gastroenteritis

Number:

04-I-0176

Summary:

This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma.

Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.

Participants undergo the following procedures:

- Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm.

- Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed.

- Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into the large intestine. Subjects are given a medication to cause relaxation through a vein before the procedure. Biopsies (removal of small amounts of tissue) are done during both endoscopies.

- Omalizumab therapy. Omalizumab is given as an injection under the skin. Following the first injection, subjects stay in the NIH Clinical Center hospital for 24 hours for safety monitoring. The remaining doses are scheduled as outpatient visits every 2 weeks after the first dose for a total of four doses. Two weeks after the last dose, patients are admitted to the Clinical Center for 2 to 3 days for repeat endoscopy, leukapheresis, skin testing, and physical examination. Additional follow-up visits are scheduled at 14 and 22 weeks after the first dose of drug for a physical examination and blood tests. If the subject's blood eosinophil count has not returned to its original baseline level by the 22 weeks visit, another visit will be scheduled at week 30.

- Symptoms scores and medication use cards. Participants must complete a symptoms score card for 3 weeks before starting omalizumab treatment. They continue record symptoms scores and medication use throughout the study. The cards are collected periodically at follow-up visits.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1) All Subjects must be at least 12 years of age and no older than 76 years of age.

2) All subjects must meet the established diagnostic criteria for eosinophilic gastroenteritis: gastrointestinal symptoms, histologic evidence of gastrointestinal tissue infiltration by eosinophils with greater than or equal to 25 eosinophils per high powered field, no known etiology for the eosinophilia despite careful clinical evaluation.

3) Eosinophilia greater than 500/mm3 at screening.

4) Baseline values within the following laboratory ranges:

- White blood cell count greater than or equal to 3,300 cells/uL

- Absolute neutrophil count greater than or equal to 1,000 cells/uL

- Hemoglobin greater than or equal to 10 g/dL

- Platelet count greater than or equal to 100,000 platelets uL

5) Evidence of atopy as defined by one of the following:

- Skin testing

- RAST testing

- Serum IgE greater than or equal to100

6) Women of childbearing potential only: negative serum Beta-hCG.

7) Agree to practice abstinence or effective contraception from initiation of the protocol and for 3 months following the last infusion of the study drug (effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap, or sponge, or hormonal contraception).

8) Weight (Kg) x serum IgE (IU/mL) less than or equal to 63,000 (per dosing restrictions).

9) Stable corticosteroid dose for one month prior to screening and willingness to continue on that dose for the first 8 weeks of the study.

10) Subjects (guardians for younger patients) must be able to give informed consent (or assent as appropriate).

EXCLUSION CRITERIA:

1) Pregnant or nursing women.

2) HIV positive or other known immunodeficiency.

3) Use of any other investigational agent within 30 days of the study.

4) Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.

Special Instructions: Currently Not Provided

Keywords:

Allergy

IgE

Eosinophil

Monoclonal Antibody

Recruitment Keywords:

Eosinophilic Gastroenteritis

EG

Conditions:

Gastroenteritis

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Lee M, Hodges WG, Huggins TL, Lee EL. Eosinophilic gastroenteritis. South Med J. 1996 Feb;89(2):189-94.

PMID: 8578348

Kelly KJ. Eosinophilic gastroenteritis. J Pediatr Gastroenterol Nutr. 2000;30 Suppl:S28-35. Review. PMID: 10634296

Park HS, Kim HS, Jang HJ. Eosinophilic gastroenteritis associated with food allergy and bronchial asthma. J Korean Med Sci. 1995 Jun;10(3):216-9. PMID: 8527050

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