Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017862
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-06-15
Brief Title:
Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Phase II Study of the Efficacy of Humanized Anti-IL5 Antibody SCH55700 in Reducing Eosinophilia in Patients With Hypereosinophilic Syndrome or Eosinophilic Gastroenteritis Refractory to or Intolerant of Conventional Therapy
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 13 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 patients local physician Follow-up visits will then be scheduled monthly for 1 year or until the patients 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
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 patients 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 13 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 patients local physician Follow-up visits will then be scheduled monthly for 1 year or until the patients 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
Detailed Description:
The purpose of this study is to evaluate the efficacy of humanized monoclonal anti-IL5 antibody SCH 55700 in reducing peripheral blood eosinophilia in patients with either hypereosinophilic syndrome or eosinophilic gastroenteritis Patients with hypereosinophilic syndrome refractory to or intolerant of therapy with conventional therapy steroids hydroxyurea and interferon alpha will be admitted on this protocol Additionally subjects with eosinophilic gastroenteritis refractory or intolerant to conventional therapy systemic glucocorticoids will be admitted on this protocol A thorough clinical evaluation will be performed with emphasis on potential sequelae of eosinophil-mediated tissue damage A baseline bone marrow will be obtained to exclude neoplasia and to assess the degree and nature of eosinophilipoiesis Blood cells andor serum will also be collected to provide reagents such as DNA RNA and specific antibodies for use in the laboratory to address issues related to the immunologic basis of FHES and GE as well as their pathogenesis and treatment Following intravenous administration of a single 1 mgkg dose of the humanized monoclonal anti-IL5 antibody SCH 55700 patients will be followed in an inpatient setting for a minimum of 72 hours for monitoring of adverse effects secondary to the infusion Followup visits will be scheduled monthly for 1 year or until the peripheral eosinophil count returns to baseline Patients showing a reduction in eosinophilia and evidence of clinical improvement will be eligible to receive 5 additional doses of 1 mgkg of SCH 55700 at monthly intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-I-0155 | None | None | None |