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Home > "P" Clinical Trials Conditions > Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus  Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
For Condition: Lupus Erythematosus, Systemic
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Michigan
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/64 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
BruceRichardson, Study Chair, University of Michigan
Additional Information:
Study ID Numbers: 199/11685; UMMC-91208
Study Start Date: February 1995
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004643
Other Lupus Erythematosus, Systemic Studies:
1. Role of altered CD40-Ligand gene transcription in systemic lupus erythematosus
2. Six month clinical research study for patients with moderate or severe dry eye syndrome
3. Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
4. Anti-CD20 in Systemic Lupus Erythematosus
5. Study of LymphoStat-B in Subjects with Systemic Lupus Erythematosus (SLE)
Related Studies:
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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
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