Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004643
• Other study ID #: 199/11685
• Secondary ID: UMMC-91208
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: February 1995

Study information

• Verified date: March 1999
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic

Intervention

Drug:
• cytarabine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Michigan

References & Publications (1)

Yung RL, Richardson BC. Cytarabine therapy for refractory cutaneous lupus. Arthritis Rheum. 1995 Sep;38(9):1341-3. — View Citation