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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus Clinical research trials and Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus. Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus clinical trial. Participants oftentimes recieve the most expert healthcare available for their Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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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. Six month clinical research study for patients with moderate or severe dry eye syndrome
2. Study of LymphoStat-B in Subjects with Systemic Lupus Erythematosus (SLE)
3. Lupus Cohort--Thrombotic Events and Coronary Artery Disease
4. Anti-CD20 in Systemic Lupus Erythematosus
5. Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
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Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus
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