Anti-IL-5 Study for Hypereosinophilic Syndrome
As you are aware, there is limited therapy available to patients with eosinophilic disorders, many who have significant sequelae from their current medication. We are currently investigating the role of a humanized monoclonal antibody directed against IL-5 (Mepolizumab, SB 204563) in these patients. IL-5 is an eosinophil growth and activating factor that has been extensively studied in pre-clinical trials. In addition, anti-human IL-5 (SB 204563) has been studied in patients with asthma and minimal side effects have been seen.
Eligibility
The eligibility is as follows:
- Age between 18 and 65 years
- 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 >3X upper limit for age
- AST >5X upper limit for age
- Platelet count <50,000 / mm3
- Cardiac function
- 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-IL5 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
If eligible, each patient will receive three doses of Mepolizumab four weeks apart. The study medication will be provided free of charge, and the study medication will be administered as an outpatient. During the initial phase of the study, if patients are on anti-eosinophil therapy, then we will decrease the dosage of their current anti-eosinophil medication so that we can evaluate the efficacy of Mepolizumab.
If you are a patient who may be interested in enrolling in this research study or you have further questions, please contact us:
Marc E. Rothenberg, MD, PhD
Bridget Buckmeier
bridget.buckmeier@cchmc.org
513-636-5540
