Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: University of Michigan
• Treatments: Cytarabine

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