Lupus Erythematosus, Systemic
Conditions
Keywords
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Brief summary
OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus. II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.
Detailed description
PROTOCOL OUTLINE: Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.
Interventions
DRUGcytarabine
Sponsors
University of Michigan
National Center for Research Resources (NCRR)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: Disease Characteristics * Clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria * Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), topical corticosteroids, and antimalarials * Intolerable side effects from corticosteroids or other immunosuppressive drugs Failure on immunosuppressives not required * No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive glomerulonephritis Prior/Concurrent Therapy * No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on study Patient Characteristics * Hematopoietic: WBC at least 2000; Platelets at least 100,000 * Renal: Creatinine clearance at least 20 mL/min * Other: No major infection within 2 weeks prior to entry * Negative pregnancy test required of fertile women * Effective contraception required of fertile women. Advised for men during and for 75 days after therapy
Outcome results
None listed