Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-02-28

Brief Summary

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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

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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.

Conditions

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Lupus Erythematosus, Systemic

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cytarabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Bruce Richardson

Role: STUDY_CHAIR

University of Michigan

References

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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.

Reference Type BACKGROUND

PMID: 7575733 (View on PubMed)

Other Identifiers

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UMMC-91208

Identifier Type: -

Identifier Source: secondary_id

199/11685