Clinical Trial: Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Phase II Study of the Efficacy of Humanized Anti-IL5 Antibody (SCH55700) in Reducing Eosinophilia in Patients With Hypereosinophilic Syndrome or Eosinophilic Gastr
Brief Summary:
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, laborator
Detailed Summary: 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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: June 15, 2001
Date Started: June 2001
Date Completion: June 2003
Last Updated: March 3, 2008
Last Verified: June 2003
