Phase I Pilot Study of Total-Body Irradiation, Anti-Thymocyte Globulin and Cyclophosphamide Followed By Syngeneic or Autologous Peripheral Blood Stem Cell Transplantation in Patients With Multiple Sclerosis
NCT ID: NCT00014755
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
35 participants
INTERVENTIONAL
1997-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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anti-thymocyte globulin
cyclophosphamide
filgrastim
prednisone
peripheral blood stem cell transplantation
irradiation
Eligibility Criteria
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Inclusion 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:
* Primary progressive disease
* Relapsing/remitting disease with 2 or more attacks in 2 years
* Secondary progressive disease
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:
* No neurologic impairment that would preclude high-dose immunosuppressive therapy
* No active uncontrolled infection
* No active malignancy
* No other illness that would severely limit life expectancy
* No medical or psychiatric conditions that would preclude study
* No history of hypersensitivity to murine proteins or E. coli-derived proteins
* No demonstrated lack of compliance with prior medical care
* Able to undergo an MRI scan
* HIV negative
* Not pregnant or nursing
18 Years
60 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
Principal Investigators
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Richard Nash
Role: STUDY_CHAIR
Fred Hutchinson Cancer Center
Locations
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City of Hope National Medical Center
Duarte, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Washington University Barnard Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Duke University Medical Center
Durham, North Carolina, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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References
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Bowen JD, Kraft GH, Wundes A, Guan Q, Maravilla KR, Gooley TA, McSweeney PA, Pavletic SZ, Openshaw H, Storb R, Wener M, McLaughlin BA, Henstorf GR, Nash RA. Autologous hematopoietic cell transplantation following high-dose immunosuppressive therapy for advanced multiple sclerosis: long-term results. Bone Marrow Transplant. 2012 Jul;47(7):946-51. doi: 10.1038/bmt.2011.208. Epub 2011 Nov 7.
Other Identifiers
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FHCRC-1164.00
Identifier Type: -
Identifier Source: secondary_id
199/15796
Identifier Type: -
Identifier Source: org_study_id