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

Inclusion 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.