High-Dose Intravenous (IV) Cyclophosphamide Versus Monthly IV Cyclophosphamide

Summary

This study compares the effectiveness of high-dose cyclophosphamide treatment with the "gold standard" treatment, monthly intravenous (IV) cyclophosphamide, in people with moderate to severe lupus that does not respond to high-dose corticosteroid therapy. We will give patients either IV cyclophosphamide (750 milligrams per square meter of body surface area) monthly for 6 months, followed by quarterly maintenance therapy, or high-dose IV cyclophosphamide (50 milligrams per kilogram body weight per day) for the first four days of the study. Patients will be followed for 24 months after therapy.

Timeline

Start

2000-01

Primary completion

2006-04

Completion

2006-04

Publications

• Background Brodsky RA, Petri M, Smith BD, Seifter EJ, Spivak JL, Styler M, Dang CV, Brodsky I, Jones RJ. Immunoablative high-dose cyclophosphamide without stem-cell rescue for refractory, severe autoimmune disease. Ann Intern Med. 1998 Dec 15;129(12):1031-5. doi: 10.7326/0003-4819-129-12-199812150-00007.
• Background Brodsky RA, Sensenbrenner LL, Jones RJ. Complete remission in severe aplastic anemia after high-dose cyclophosphamide without bone marrow transplantation. Blood. 1996 Jan 15;87(2):491-4.
• Background Brodsky RA, Smith BD. Bone marrow transplantation for autoimmune diseases. Curr Opin Oncol. 1999 Mar;11(2):83-6. doi: 10.1097/00001622-199903000-00002.
• Background Levite M, Zinger H, Zisman E, Reisner Y, Mozes E. Beneficial effects of bone marrow transplantation on the serological manifestations and kidney pathology of experimental systemic lupus erythematosus. Cell Immunol. 1995 Apr 15;162(1):138-45. doi: 10.1006/cimm.1995.1061.
• Background Petri M, Jones RJ, Brodsky RA. High-dose cyclophosphamide without stem cell transplantation in systemic lupus erythematosus. Arthritis Rheum. 2003 Jan;48(1):166-73. doi: 10.1002/art.10752.
• Background Petri M. Cyclophosphamide: new approaches for systemic lupus erythematosus. Lupus. 2004;13(5):366-71. doi: 10.1191/0961203303lu1028oa.

Drugs

Indications