Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: cytarabine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004643

199/11685

UMMC-91208

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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