Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

Investigators

  • Study Chair: Bruce Richardson, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1995

Study Registration Dates

First Submitted

February 24, 2000

First Submitted That Met QC Criteria

February 24, 2000

First Posted (Estimate)

February 25, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/11685
  • UMMC-91208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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