Phase I Study 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
NCT ID: NCT00017628
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2001-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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cyclophosphamide
filgrastim
methylprednisolone
Autologous Stem Cell Transplantation
Eligibility Criteria
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Inclusion 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:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* 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 prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage I breast cancer, are considered on an individual basis)
* No presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip
0 Years
59 Years
ALL
No
Sponsors
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Northwestern Memorial Hospital
OTHER
Principal Investigators
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Richard K. Burt
Role: STUDY_CHAIR
Northwestern Memorial Hospital
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Countries
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Other Identifiers
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NU-95MS1
Identifier Type: -
Identifier Source: secondary_id
199/14975
Identifier Type: -
Identifier Source: org_study_id