Phase I Study of Immune Ablation and CD34+ Peripheral Blood Stem Cell Support in Patients With Systemic Lupus Erythematosus

You may be eligible if

• PROTOCOL ENTRY CRITERIA:
• -Disease Characteristics--
• Diagnosis of systemic lupus erythematosus with 1 of the following malignant features:
• Nephritis (WHO class III or IV)
• Failed NIH short-course cyclophosphamide therapy
• Vasculitis/immune complex deposition causing end organ signs or symptoms (e.g., cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, or renal failure)
• Hematologic cytopenias that are immune mediated and uncontrolled by conservative measures with any of the following:
• Transfusion-dependent anemia with untransfused hemoglobin less than 8 g/dL
• Platelet count less than 40,000/mm3 (without transfusions)
• Granulocyte count less than 1,000/mm3
• Catastrophic anti-phospholipid syndrome
• -Patient Characteristics--
• Cardiovascular:
• LVEF at least 35%
• No lupus-induced myocarditis
• No history of unstable angina
• Pulmonary:
• FEV1/FVC at least 50% predicted
• DLCO at least 50% predicted
• Other:
• HIV negative
• No prior or concurrent malignancy except localized basal cell or squamous cell skin cancer
• No uncontrolled diabetes mellitus
• No medical illness that would preclude study
• No psychiatric illness or mental deficiency that would preclude study
• No known hypersensitivity to E. coli-derived proteins
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception