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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

This study has been completed.
Sponsor:
Collaborator:
University of Michigan
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004643
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: March 1999
History of Changes
  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: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: 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:

ClinicalTrials.gov Identifier: NCT00004643     History of Changes
Other Study ID Numbers: 199/11685, UMMC-91208
Study First Received: February 24, 2000
Last Updated: June 23, 2005
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:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013