Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
National Center for Research Resources (NCRR)
With
University of Michigan
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.
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
