Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's Granulomatosis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Dec 9, 2002

Keywords

ClinConnect Summary

The purpose of the study is to assess the safety, tolerance, and immunologic effects of interleukin-10 (IL-10), in patients with Wegener's granulomatosis. A secondary objective is to determine if IL-10 demonstrates sufficient anti-inflammatory activity in the treatment of Wegener's granulomatosis to warrant further study in a larger trial. In this study, IL-10 will be given either alone or in combination with standard therapeutic agents, usually consisting of cyclophosphamide, methotrexate, and/or prednisone. Patients will be eligible to receive IL-10 when there is evidence of active diseas...

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ALL

Eligibility criteria

• • Diagnosis of Wegener's granulomatosis based on clinical characteristics and histopathological and/or angiographic evidence of vasculitis or the presence of glomerulonephritis and a positive assay for anti-neutrophil cytoplasmic autoantibodies (ANCA).
• • Age between 18 to 65 years.
• No change in immunosuppressive drug therapy during the prior 4 weeks and one of the following:
• • Persistent disease activity ("Vasculitis Activity Index" score of greater than or equal to 3) despite optimal therapy;
• • Persistent or recurrent disease activity in a patient who cannot tolerate optimal therapy;
• • Patients not on maximal immunosuppressive therapy but with persistent or recurrent disease activity that is not, in the judgment of investigators, immediately threatening the function of a major organ system;
• • No evidence of active infection.
• • Patients may not be pregnant or nursing infants. Fertile women must have a negative pregnancy test within one week prior to study entry and all participants must be using effective means of birth control.
• • Serum creatinine is less than 3.5 mg/dL.
• • Hemocytopenia (platelet count is greater than 100,000/mm(3), leukocyte count is greater than 3,500/mm(s), hemoglobin is greater than 9 mg/dL).
• • Liver function test abnormalities is less than 3x upper limits of normal (either serum GOT, GPT, alkaline phosphatase, and/or bilirubin).
• • Patients cannot be anti-HIV, anti-HCV, or anti-Hepatitis B surface antigen (HBsAG) positive.
• • Weight greater less than 104 Kg (because of SCH 52000 concentration and volume limitations for subcutaneous injection).
• • No treatment with any investigational drug within 30 days.
• • No pre-existing malignancy.
• • No known allergy to E. coli protein or IL-10.
• • No history of psychiatric illness that in the opinion of the principal investigator would preclude entrance into the study.