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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004643
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Michigan
Information provided by:
Office of Rare Diseases (ORD)
  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 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004643


Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Michigan
Investigators
Study Chair: Bruce Richardson University of Michigan
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004643     History of Changes
Other Study ID Numbers: 199/11685
UMMC-91208
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
Last Verified: March 1999

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:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs