Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

cytarabine

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004643

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00004643

Brief Title

Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

Study Type

Interventional

2. Study Status

Record Verification Date

March 1999

Overall Recruitment Status

Completed

Study Start Date

February 1995 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lupus Erythematosus, Systemic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

Enrollment

10 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

cytarabine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Richardson

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

7575733

Citation

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.

Results Reference

background

Lupus Erythematosus, Systemic

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial