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

Primary Purpose

Hypereosinophilic Syndromes, Eosinophilic Gastroenteritis, Churg-Strauss Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mepolizumab
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypereosinophilic Syndromes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti-IL5 (Mepolizumab)

Arm Description

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.

Outcomes

Primary Outcome Measures

To assess the toxicity of anti-IL-5 in patients with hypereosinophilia

Secondary Outcome Measures

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

Full Information

First Posted
December 15, 2005
Last Updated
July 27, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT00266565
Brief Title
Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2001 (Actual)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Toxicity of anti-IL-5
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypereosinophilic Syndromes, Eosinophilic Gastroenteritis, Churg-Strauss Syndrome, Eosinophilic Esophagitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anti-IL5 (Mepolizumab)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Mepolizumab
Other Intervention Name(s)
Anti-IL5
Intervention Description
10mg/kg (max 750 ml) once a month for 3 months
Primary Outcome Measure Information:
Title
To assess the toxicity of anti-IL-5 in patients with hypereosinophilia
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia
Time Frame
28 weeks
Title
To assess whether anti-IL-5 has a steroid and/or interferon sparing effect
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc E. Rothenberg, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States

12. IPD Sharing Statement

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

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