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This study will examine the safety and effectiveness of a single dose of anti-interleukin-5 antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in patients with hypereosinophilic syndrome. Patients with this disease have too many eosinophils in the blood and in body tissues, which cause damage to the affected organs-most commonly the heart, nerves and skin. SCH 55700 is an antibody to interleukin 5-a hormone-like substance produced by white blood cells that plays a significant role in eosinophilia. SCH 55700 has lowered eosinophilia blood counts in patients with asthma and reduced the number of these cells in tissues of animals with asthma.
Patients with hypereosinophilic syndrome 18 years of age and older who have not responded to standard therapy with steroids, interferon and hydroxyurea or cannot take these drugs may be eligible for this study. Candidates will be screened with a medical history, physical examination, eye examination, and blood tests. Depending on the patient's symptoms, other diagnostic tests may be done, including studies of the eyes, lungs, skin, nerves or heart. Skin biopsy and bronchoalveolar lavage may be included in the diagnostic evaluation. For the skin biopsy, a small area about 1/3 inch in diameter is numbed and a small core of skin is surgically removed for study under the microscope. Bronchoalveolar lavage involves inserting a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue sample. This test will be done only if clinically necessary.
Those enrolled in the study will be admitted to the NIH Clinical Center for a single dose of SCH 55700, injected into an arm vein. They will be monitored in the hospital for at least 72 hours for changes in eosinophil count and side effects of the injection. After discharge, laboratory tests will be done weekly for the first month, either at the Clinical Center or by the patient's local physician. Follow-up visits will then be scheduled monthly for 1 year or until the patient's eosinophil count returns to pre-treatment levels for 2 consecutive months. Follow-up visits will include a history, physical examination and blood tests, including studies on how immune cells and other substances in the blood activate or stimulate eosinophilia. A chest X-ray, electrocardiogram and pulmonary function tests will be done at 1, 3, 6 and 12 months to evaluate organ damage. Other tests may be done if medically indicated.
Bone marrow biopsy and aspiration will be done before receiving SCH 55700 and one month after the injection to evaluate the effects of SCH 55700 on eosinophil production in the bone marrow. For this test, an area of skin and bone is numbed and a very sharp needle is used to withdraw a sample of the bone marrow. Leukapheresis will also be done before and 1 month after SCH 55700 treatment to obtain cells for studying the effect of SCH 55700 on eosinophil activation, function and survival. For this procedure, whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The white cells are then removed, and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm.
The purpose of this study is to evaluate the efficacy of humanized monoclonal anti-IL5 antibody, SCH 55700 in reducing peripheral blood eosinophilia in patients with either hypereosinophilic syndrome or eosinophilic gastroenteritis. Patients with hypereosinophilic syndrome refractory to or intolerant of therapy with conventional therapy (steroids, hydroxyurea and interferon alpha) will be admitted on this protocol. Additionally, subjects with eosinophilic gastroenteritis refractory or intolerant to conventional therapy (systemic glucocorticoids) will be admitted on this protocol. A thorough clinical evaluation will be performed with emphasis on potential sequelae of eosinophil-mediated tissue damage. A baseline bone marrow will be obtained to exclude neoplasia and to assess the degree and nature of eosinophilipoiesis. Blood cells and/or serum will also be collected to provide reagents (such as DNA, RNA, and specific antibodies) for use in the laboratory to address issues related to the immunologic basis of FHES and GE as well as their pathogenesis and treatment. Following intravenous administration of a single 1 mg/kg dose of the humanized monoclonal anti-IL5 antibody, SCH 55700, patients will be followed in an inpatient setting for a minimum of 72 hours for monitoring of adverse effects secondary to the infusion. Followup visits will be scheduled monthly for 1 year or until the peripheral eosinophil count returns to baseline. Patients showing a reduction in eosinophilia and evidence of clinical improvement will be eligible to receive 5 additional doses of 1 mg/kg of SCH 55700 at monthly intervals.
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:56:49-0400
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