Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Apr 26, 2002

Keywords

ClinConnect 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...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA - HES:
• • All subjects must meet the established diagnostic criteria for idiopathic hypereosinophilic syndrome: eosinophilia greater than 1,500/mm3 on two occasions at least 6 months apart, no known etiology for the eosinophilia despite careful clinical evaluation, evidence of end organ damage (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporarily associated with eosinophilia and not clearly attributable to another cause).
• • All subjects must be at least 18 years of age.
• • Failure of or contraindication to treatment with steroids, interferon alpha and hydroxyurea
• • Negative serum beta-hCG within 24 hours of drug administration for women of childbearing potential must to exclude early pregnancy
• • Agree to practice abstinence or effective contraception for 6 months following administration of the study drug
• INCLUSION CRITERIA - EG:
• • 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
• • Eosinophilia greater than 860/mm3 on two occasions at least 6 months apart
• • Evidence of hypersensitivity to foods or aeroallergens as determined by skin or RAST testing
• • All subjects must be at least 18 years of age.
• • Failure of or contraindication to treatment with steroids.
• • Negative serum beta-hCG within 24 hours of drug administration for women of childbearing potential must to exclude early pregnancy
• • Agree to practice abstinence or effective contraception for 6 months following administration of the study drug
• EXCLUSION CRITERIA - HES and GE:
• • Pregnant or nursing women
• • HIV positivity or other known immunodeficiency
• • Use of any other investigational agent within 30 days of the study
• • Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.