Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome

Study Description

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Brief Summary:

Toxicity of anti-IL-5

Condition or disease	Intervention/treatment	Phase
Hypereosinophilic Syndromes; Eosinophilic Gastroenteritis; Churg-Strauss Syndrome; Eosinophilic Esophagitis	Drug: Mepolizumab	Phase 1; Phase 2

Detailed Description:

The purpose of the study is to assess the toxicity of anti-IL-5, and to see whether it lowers peripheral blood eosinophils and/or tissue and whether it has a steroid and/or interferon sparing effect.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes
Study Start Date :	December 2001
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Anti-IL5 (Mepolizumab); The purpose of the study is to assess the toxicity of anti-IL-5 (Mepolizumab), and to see whether it lowers eosinophils in peripheral blood and/or tissue and whether it has a steroid and/or interferon sparing effect.	Drug: Mepolizumab; 10mg/kg (max 750 ml) once a month for 3 months; Other Name: Anti-IL5

Outcome Measures

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Primary Outcome Measures :

1. To assess the toxicity of anti-IL-5 in patients with hypereosinophilia [ Time Frame: 8 years ]

Secondary Outcome Measures :

1. To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia [ Time Frame: 8 years ]
2. To assess whether anti-IL-5 has a steroid and/or interferon sparing effect [ Time Frame: 8 years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Adequate renal, cardiac, and hepatic function
• Not pregnant or breastfeeding

• A diagnosis of hypereosinophilic syndrome such as:

  • Idiopathic hypereosinophilic syndrome;
  • Eosinophilia myalgia syndrome;
  • Eosinophilic gastroenteritis;
  • Churg-Strauss syndrome;
  • Eosinophilic cellulitis;
  • Benign hypereosinophilia; or
  • Eosinophilic esophagitis.
• Maintained on, or in need of, the following: glucocorticoids, interferon, methotrexate, hydroxyurea, cytoxan, 6-mercaptopurine, or vincristine
• Blood eosinophil counts greater than 750 cells/mcl

Exclusion Criteria:

• Creatinine > 3 X upper limit for age
• AST > 5 X upper limit for age
• Platelet count < 50,000/mm3

• Cardiac function:

  1. NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
  2. Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
  3. Patients requiring IV heart failure medications;
  4. Angina or acute myocardial infarction
• History of renal, hepatic, endocrine, oncologic, cardiovascular disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the patient or impact on the validity of the study results
• History of allergic or adverse response to previous antibody type therapy
• History of allergic or adverse response to anti-IL-5 therapy
• Evidence of, or history of, a parasitic infection (within past 1 year)
• Participation in a previous clinical trial involving an investigational agent within 30 days prior to study initiation
• Receipt of anti-IL-5 therapy in the past
• Blood donation of 450 ml (1 pint) or more within 30 days prior to study initiation
• Abnormal or unusual diet or substantial changes in eating habits within 30 days prior to, or during, the study.
• Patients who do not have eosinophil levels > 750 cells/mcl after the run-in period. Patients who have only eosinophilic infiltration of tissue are eligible if they do not develop an eosinophil level > 750 cells/mcl, assuming that they meet all other eligibility requirements.
• Positive serum pregnancy test
• Breastfeeding
• Unable to use effective birth control methods for duration of study
• Unable or unwilling to give voluntary informed consent/assent

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator:	Marc E. Rothenberg, MD	Children's Hospital Medical Center, Cincinnati

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:	NCT00266565 History of Changes
Other Study ID Numbers:	01-9-18; FD-R-002396
First Posted:	December 19, 2005
Last Update Posted:	January 23, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:

Syndrome; Esophagitis; Gastroenteritis; Eosinophilic Esophagitis; Hypereosinophilic Syndrome; Churg-Strauss Syndrome; Enteritis; Eosinophilia; Gastritis; Disease; Pathologic Processes; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Leukocyte Disorders	Hematologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Autoimmune Diseases; Intestinal Diseases; Stomach Diseases