Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Michigan
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004643

Purpose

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.

Condition	Intervention	Phase
Lupus Erythematosus, Systemic	Drug: cytarabine	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label

Resource links provided by NLM:

MedlinePlus related topics: Lupus

Drug Information available for: Cytarabine hydrochloride Cytarabine

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	10
Study Start Date:	February 1995

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004643

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Michigan

Investigators

Study Chair:

Bruce Richardson

University of Michigan

More Information

Publications:

Yung RL, Richardson BC. Cytarabine therapy for refractory cutaneous lupus. Arthritis Rheum. 1995 Sep;38(9):1341-3. No abstract available.

Study ID Numbers:	199/11685, UMMC-91208
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004643 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

arthritis & connective tissue diseases
immunologic disorders and infectious disorders
rare disease
systemic lupus erythematosus

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Autoimmune Diseases
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Lupus Erythematosus, Systemic
Therapeutic Uses
Connective Tissue Diseases
Cytarabine

ClinicalTrials.gov processed this record on November 09, 2009