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

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT00266565

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

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

Actual Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Apr 1, 2005

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

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 Names: Anti-IL5

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 Names:

Anti-IL5

Outcome Measures

Primary Outcome Measures

To assess the toxicity of anti-IL-5 in patients with hypereosinophilia [28 weeks]

Secondary Outcome Measures

To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia [28 weeks]
To assess whether anti-IL-5 has a steroid and/or interferon sparing effect [28 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

NYHA class IIIb or IV (patients with shortness of breath or fatigue with mild exertion or at rest);
Patients with symptomatic supraventricular or ventricular arrythmias requiring treatment;
Patients requiring IV heart failure medications;
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