NCT00004643

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1995

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1999

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Lupus Erythematosus, Systemic

Keywords

arthritis & connective tissue diseasesimmunologic disorders and infectious disordersrare diseasesystemic lupus erythematosus

Interventions

cytarabineDRUG

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Yung RL, Richardson BC. Cytarabine therapy for refractory cutaneous lupus. Arthritis Rheum. 1995 Sep;38(9):1341-3. doi: 10.1002/art.1780380926. No abstract available.

    PMID: 7575733BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritisConnective Tissue DiseasesImmune System DiseasesCommunicable DiseasesRare Diseases

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Bruce Richardson

    University of Michigan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

February 1, 1995

Last Updated

June 24, 2005

Record last verified: 1999-03