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Sponsored by: |
Fred Hutchinson Cancer Research Center |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00014755 |
OBJECTIVES: I. Determine the toxicity of total-body irradiation, anti-thymocyte globulin, and cyclophosphamide followed by syngeneic or autologous peripheral blood stem cell (PBSC) transplantation in patients with multiple sclerosis.
II. Determine the disease response of patients treated with this regimen. III. Determine the safety and efficacy of filgrastim (G-CSF) for PBSC mobilization in this patient population.
Condition | Intervention | Phase |
---|---|---|
Multiple Sclerosis |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: filgrastim Drug: prednisone Procedure: peripheral blood stem cell transplantation Procedure: irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 35 |
Study Start Date: | December 1997 |
PROTOCOL OUTLINE: This is a multicenter study. Patients receive oral prednisone on days 0-10. Beginning on day 1, patients undergoing autologous peripheral blood stem cell (PBSC) transplantation receive filgrastim (G-CSF) subcutaneously daily until leukapheresis is completed. Leukapheresis begins on approximately day 4 and continues until adequate CD34+ PBSC are collected.
PBSC are collected from syngeneic donors in a similar manner. Patients undergo total-body irradiation twice daily on days -5 and -4. Patients receive cyclophosphamide IV on days -3 and -2 and anti-thymocyte globulin IV on days -5, -3, -1, 1, 3, and 5. Patients undergo autologous or syngeneic PBSC transplantation on day 0. Following PBSC transplantation, patients receive oral prednisone on days 7-30 and G-CSF IV daily beginning on day 0 and continuing until blood counts recover.
Patients are followed at 30, 80, and 90 days, monthly for 6 months, and then at 1 and 2 years.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of rapidly progressive multiple sclerosis (MS) by Proser criteria and at high risk for a fatal outcome or severe disability with one of the following:
Extended disability status scale (EDSS) between 5.0 and 8.0 with deterioration in the EDSS of 1 or more points over the past year
More than 60 days since relapse of MS
No evidence of myelodysplasia
Sibling donor proven to be an identical twin by ABO typing, HLA typing, and VNTR analysis (for syngeneic transplantation)
--Prior/Concurrent Therapy--
Radiotherapy: No prior total-lymphoid irradiation
Other: No other concurrent investigational agents
--Patient Characteristics-- Hepatic: No hepatic impairment that would preclude high-dose immunosuppressive therapy
Renal: No renal impairment that would preclude high-dose immunosuppressive therapy
Cardiovascular: No cardiac impairment that would preclude high-dose immunosuppressive therapy
Pulmonary: No pulmonary impairment that would preclude high-dose immunosuppressive therapy
Other:
United States, California | |
City of Hope National Medical Center | |
Duarte, California, United States, 91010 | |
United States, Colorado | |
University of Colorado Cancer Center | |
Denver, Colorado, United States, 80262 | |
United States, Missouri | |
Washington University Barnard Cancer Center | |
Saint Louis, Missouri, United States, 63110 | |
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-3330 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | Richard Nash | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | 199/15796, FHCRC-1164.00 |
Study First Received: | April 10, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00014755 |
Health Authority: | Unspecified |
multiple sclerosis neurologic and psychiatric disorders rare disease |
Antilymphocyte Serum Prednisone Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Mental Disorders |
Rare Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating diseases Sclerosis Cyclophosphamide Autoimmune Diseases of the Nervous System |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones |
Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |