Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
Status:
Completed
Trial end date:
2003-06-01
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effectiveness of a single dose of anti-interleukin-5
antibody (SCH 55700) in reducing the number of eosinophils (a type of white blood cell) in
patients with hypereosinophilic syndrome. Patients with this disease have too many
eosinophils in the blood and in body tissues, which cause damage to the affected organs-most
commonly the heart, nerves and skin. SCH 55700 is an antibody to interleukin 5-a hormone-like
substance produced by white blood cells that plays a significant role in eosinophilia. SCH
55700 has lowered eosinophilia blood counts in patients with asthma and reduced the number of
these cells in tissues of animals with asthma.
Patients with hypereosinophilic syndrome 18 years of age and older who have not responded to
standard therapy with steroids, interferon and hydroxyurea or cannot take these drugs may be
eligible for this study. Candidates will be screened with a medical history, physical
examination, eye examination, and blood tests. Depending on the patient's symptoms, other
diagnostic tests may be done, including studies of the eyes, lungs, skin, nerves or heart.
Skin biopsy and bronchoalveolar lavage may be included in the diagnostic evaluation. For the
skin biopsy, a small area about 1/3 inch in diameter is numbed and a small core of skin is
surgically removed for study under the microscope. Bronchoalveolar lavage involves inserting
a catheter (flexible tube) into the lungs to instill saline (salt water) and obtain a tissue
sample. This test will be done only if clinically necessary.
Those enrolled in the study will be admitted to the NIH Clinical Center for a single dose of
SCH 55700, injected into an arm vein. They will be monitored in the hospital for at least 72
hours for changes in eosinophil count and side effects of the injection. After discharge,
laboratory tests will be done weekly for the first month, either at the Clinical Center or by
the patient's local physician. Follow-up visits will then be scheduled monthly for 1 year or
until the patient's eosinophil count returns to pre-treatment levels for 2 consecutive
months. Follow-up visits will include a history, physical examination and blood tests,
including studies on how immune cells and other substances in the blood activate or stimulate
eosinophilia. A chest X-ray, electrocardiogram and pulmonary function tests will be done at
1, 3, 6 and 12 months to evaluate organ damage. Other tests may be done if medically
indicated.
Bone marrow biopsy and aspiration will be done before receiving SCH 55700 and one month after
the injection to evaluate the effects of SCH 55700 on eosinophil production in the bone
marrow. For this test, an area of skin and bone is numbed and a very sharp needle is used to
withdraw a sample of the bone marrow. Leukapheresis will also be done before and 1 month
after SCH 55700 treatment to obtain cells for studying the effect of SCH 55700 on eosinophil
activation, function and survival. For this procedure, whole blood is collected through a
needle in an arm vein. The blood circulates through a machine that separates it into its
components. The white cells are then removed, and the rest of the blood is returned to the
body, either through the same needle used to draw the blood or through a second needle placed
in the other arm.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)