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Sponsored by: |
Northwestern Memorial Hospital |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00017628 |
OBJECTIVES:
I. Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis.
Condition | Intervention | Phase |
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Multiple Sclerosis |
Drug: cyclophosphamide Drug: filgrastim Drug: methylprednisolone Procedure: Autologous Stem Cell Transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Estimated Enrollment: | 20 |
Study Start Date: | April 2001 |
PROTOCOL OUTLINE: Following an induction course of cyclophosphamide IV, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Harvested PBSCs or bone marrow then undergo T-lymphocyte depletion.
Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV daily on days -4 to -1. Patients also undergo total body irradiation twice a day on days -4 to -1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days.
Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.
Ages Eligible for Study: | up to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Diagnosis of multiple sclerosis Kurtzke score of 4.0-7.5 Increase of 1.0 point over the past 12 months More than 3 relapses in 24 months despite conventional disease modifying therapy Failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone IV
--Prior/Concurrent Therapy--
Chemotherapy: No prior cladribine
Radiotherapy: No prior radiotherapy to greater than 10 cm2 of lung tissue No prior craniospinal irradiation No prior total lymphoid irradiation
--Patient Characteristics--
Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL
Hepatic: Hepatitis B antigen negative Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal
Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of coronary artery disease Resting LVEF at least 45%
Pulmonary: FEV1/FVC at least 75% predicted DLCO at least 50% predicted
Other:
United States, Illinois | |
Northwestern Memorial Hospital | |
Chicago, Illinois, United States, 60611 | |
Rush-Presbyterian-St. Luke's Medical Center | |
Chicago, Illinois, United States, 60612 |
Study Chair: | Richard K. Burt | Northwestern Memorial Hospital |
Study ID Numbers: | 199/14975, NU-95MS1 |
Study First Received: | June 6, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00017628 |
Health Authority: | Unspecified |
multiple sclerosis neurologic and psychiatric disorders rare disease |
Autoimmune Diseases Demyelinating Diseases Methylprednisolone Rare Diseases Methylprednisolone acetate Prednisolone acetate Sclerosis Demyelinating diseases |
Cyclophosphamide Multiple Sclerosis Mental Disorders Prednisolone Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Neuroprotective Agents Hormones Pathologic Processes Therapeutic Uses Alkylating Agents Antineoplastic Agents, Hormonal |
Immune System Diseases Nervous System Diseases Gastrointestinal Agents Immunosuppressive Agents Protective Agents Glucocorticoids Pharmacologic Actions Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |