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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marc Rothenberg, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00266565
First received: December 15, 2005
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Hypereosinophilic Syndromes
Eosinophilic Gastroenteritis
Churg-Strauss Syndrome
Eosinophilic Esophagitis
Drug: Mepolizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • To assess the toxicity of anti-IL-5 in patients with hypereosinophilia [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess whether anti-IL-5 lowers peripheral blood eosinophils and/or tissue in patients with hypereosinophilia [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • To assess whether anti-IL-5 has a steroid and/or interferon sparing effect [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2001
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mepolizumab
    10mg/kg (max 750 ml) once a month for 3 months
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266565

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Sponsors and Collaborators
Marc Rothenberg
Investigators
Principal Investigator: Marc E. Rothenberg, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Marc Rothenberg, MD, PhD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00266565     History of Changes
Other Study ID Numbers: 01-9-18, FD-R-002396
Study First Received: December 15, 2005
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014