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Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis Clinical research trials and Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis  Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis,Juvenile Rheumatoid Arthritis
Status: Recruiting
Sponsor(s): Northwestern Memorial Hospital ,
Synopsis: OBJECTIVES: I. Determine the toxicity of high-dose cyclophosphamide, anti-thymocyte globulin, and total body irradiation with T-cell-depleted autologous bone marrow rescue in patients with high-risk rheumatoid arthritis. II. Determine the safety and efficacy of this regimen in this patient population.
Details: PROTOCOL OUTLINE: Patients undergo peripheral blood stem cell (PBSC) harvest after induction therapy. Patients receive 2 doses of cyclophosphamide IV over 1 hour given 3 hours apart followed 24 hours later by filgrastim (G-CSF) subcutaneously (SC). G-CSF continues daily until after leukapheresis. Harvested PBSCs then undergo T-lymphocyte depletion. Patients undergo conditioning regimen of total body irradiation on day -6, cyclophosphamide IV over 1 hour on days -5 through -2 and anti-thymocyte globulin IV over 12 hours beginning 10 hours after cyclophosphamide on days -4 through -2. Lymphocyte-depleted PBSCs are reinfused on day 0. Patients also receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover. Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /59 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Clinical diagnosis of rheumatoid arthritis by American College of Rheumatology criteria Positive rheumatoid factor - Treatment failure following therapy with 2 of the following disease-modifying agents: Methotrexate Azathioprine Plaquenil Asulfidine Gold D-penicillamine - Must have 6 swollen joints from active rheumatoid arthritis AND EITHER 30 or more involved joints (swelling, tenderness, deformity, pain on motion, or decreased motion) OR Responded "without any difficulty" to less than 75% of questions on Health Assessment Questionnaire - Juvenile rheumatoid arthritis allowed if onset of disease is either polyarthritic or systemic Must have at least 6 swollen joints Treatment failure after corticosteroids and 2 disease-modifying agents --Patient Characteristics-- - Age: Under 60 at time of pretransplantation evaluation - Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No coronary artery disease or congestive heart failure Resting LVEF at least 45% - Pulmonary: FEV1/FVC at least 75% predicted DLCO at least 50% predicted - Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception Must be willing to accept and/or comprehend irreversible sterility as a side effect of therapy HIV negative No uncontrolled diabetes mellitus No other concurrent medical illness that would preclude study No concurrent psychiatric illness or mental deficiency that would preclude study No history of malignancy except localized basal cell or squamous cell skin cancer (malignancies such as head and neck cancer and stage I breast cancer curatively treated with local surgical excision considered on an individual basis) No known history of allergy to eggs or murine proteins No known hypersensitivity to E.coli-derived proteins
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
RichardBurt, Study Chair, Northwestern Memorial Hospital
Northwestern University Medical School *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Richard Pope 312-503-8003
Northwestern Memorial Hospital *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Bharat Mittal 312-926-2520
University of Wisconsin Hospital and Clinics *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting Frank Graziano 608-263-6186
Additional Information:
Study ID Numbers: 199/14973; NU-96RA1
Study Start Date: April 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017615
Other Juvenile Rheumatoid Arthritis Studies:
1. Safety and efficacy of a monoclonal antibody for treatment of rheumatoid arthritis.
2. Oral Collagen for Rheumatoid Arthritis
3. Study to Assess Efficacy of Tacrolimus + Methotrexate Vs. Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
4. Clinically Important Changes in Rheumatoid Arthritis
5. Lung Disease Associated with Rheumatoid Arthritis
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Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
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