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

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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

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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia

Condition

Hypereosinophilic Syndromes

Intervention

Mepolizumab

Study Arms / Comparison Groups

 Anti-IL5 (Mepolizumab)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

December 2001

Completion Date

April 2005

Primary Completion Date

April 2005

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:

               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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Marc E. Rothenberg, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00266565

Organization ID

01-9-18

Secondary IDs

FD-R-002396

Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati


Study Sponsor

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


Verification Date

July 2020