Cytarabine Treatment for Refractory Systemic Lupus Erythematosus
cytarabine
Autoimmune Diseases+11
+ Infections
+ Joint Diseases
Treatment Study
Summary
Study start date: February 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 64 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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