Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

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.

Completed

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Key information

Conditions

Lupus Erythematosus, Systemic Arthritis Autoimmune Diseases Communicable Diseases Connective Tissue Diseases Disease Attributes Immune System Diseases Infections Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of Michigan

Registry information

Important dates

Study start: 1995
First posted: Feb 25, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed