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A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis 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 A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis Clinical research trials and A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis 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 A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis. A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis 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 A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis clinical trial. Test subjects oftentimes recieve the best healthcare possible for their A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis 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 > "A" Clinical Trials Conditions > A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis  A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis
A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis
For Condition: Multiple Sclerosis
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Stanford University
Synopsis: OBJECTIVES: I. Evaluate the safety and immunogenicity of single and multiple doses of M-T412, a chimeric murine-human anti-CD4 monoclonal antibody, in patients with multiple sclerosis. II. Evaluate the pharmacokinetics of M-T412. III. Obtain preliminary data on the clinical response to M-T412.
Details: PROTOCOL OUTLINE: This is an open label, dose escalating study. Escalating doses of M-T412 are administered to cohorts of 5 patients each receiving a single dose intravenously over 2 hours. Patients who complete the single dose assessment of M-T412 may receive up to 3 additional single doses of M-T412 IV over 2 hours, with each repeated dose given at least 1 month apart. Then, patients receive one dose level of M-T412 IV over 2 hours at 3 month intervals over a period of 12 months for a total of 5 doses. Once recovery of CD4 cells is obtained, the next scheduled infusion of M-T412 begins. Patients are omitted from study if CD4 cells remain attenuated following 2 scheduled infusion sessions. Patients are followed at 3, 6, 12, and 24 months after the first infusion.
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of chronic, advanced, progressive multiple sclerosis (MS) --Prior/Concurrent Therapy-- - Biologic therapy: No sensitivity to murine proteins No prior treatment at any time with anti-CD4 antibodies, other murine antibodies, or other anti-T cell antibodies (e.g., xenologous or human) At least 4 weeks since use of other biological agents - Chemotherapy: No concomitant chemotherapy At least 3 months since prior chemotherapy - Endocrine therapy: No concomitant steroidal therapy At least 3 months since prior steroidal therapy - Radiotherapy: No total lymphoid irradiation prior to study No concomitant radiotherapy At least 3 months since prior radiotherapy - Other: No use of investigational drugs within 30 days prior to study --Patient Characteristics-- - Age: 21 to 75 - Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 4000/mm3 Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 CD4+ lymphocyte count at least 300 cells/mm3 - Other: Not pregnant or lactating Effective contraception required of fertile patients for 3 months prior to and during study No substance abuse (e.g., drug or alcohol) Not HIV positive No AIDS-Related Complex (ARC) No serum antibodies to HIV Negative serum antibody test for HIV within 1 month prior to study No underlying medical or psychiatric condition
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
LawrenceSteinman, Study Chair, Stanford University
Additional Information:
Study ID Numbers: 199/12050; SUMC-C0128T03
Study Start Date: July 1995
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004816
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A Maintenance Extension of Phase I Pilot Study of Chimeric Anti-CD4 Antibody M-T412 in Patients With Multiple Sclerosis
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