Daclizumab to Treat Wegener's Granulomatosis

Exclusion Criteria

• •Evidence of active infection which, in the judgement of the investigator, is of greater danger to the patient than the underlying vasculitis.
• •Patients who are pregnant or who are nursing infants will not be eligible. Women of childbearing potential must have a negative pregnancy test within one week prior to study entry.
• •Serological evidence of infection with human immunodeficiency virus (HIV), hepatitis C, or a positive hepatitis B surface antigen. A serological determination will be performed within two weeks of beginning study participation.
• •Acute or chronic liver disease, past history of alcohol abuse (greater than 14 oz of 100 proof liquor or equivalent per week), ongoing alcohol use of any volume that cannot be discontinued upon entry into the study.
• •History of CYC- or methotrexate-induced pneumonitis or other hypersensitivity reactions to these drugs with past treatment.
• •History of transitional cell carcinoma (TCC) of the bladder.
• •History of any malignant neoplasm except in situ anogenital carcinoma, adequately treated basal or squamous cell carcinoma of the skin, or solid tumors (other than TCC of the bladder cancer) treated with curative therapy and disease free for at least 5 years.
• •Inability to comply with study guidelines.
• •Hemocytopenia: platelet count less than 80,000/mm(3), absolute neutrophil count less than 1500/mm(3), hematocrit less than 20% (in the absence of gastrointestinal bleeding or hemolytic anemia).
• •Known allergy to murine proteins.