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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
This study has been completed.
First Received: April 10, 2001   Last Updated: June 23, 2005   History of Changes
Sponsored by: Fred Hutchinson Cancer Research Center
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00014755
  Purpose

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

MedlinePlus related topics: Cancer Multiple Sclerosis Radiation Therapy
Drug Information available for: Cyclophosphamide Prednisone Filgrastim
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 35
Study Start Date: December 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014755

Locations
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
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Richard Nash Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Study ID Numbers: 199/15796, FHCRC-1164.00
Study First Received: April 10, 2001
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00014755     History of Changes
Health Authority: Unspecified

Keywords provided by Office of Rare Diseases (ORD):
multiple sclerosis
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Demyelinating Diseases
Immunologic Factors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Rare Diseases
Sclerosis
Cyclophosphamide
Hormones
Glucocorticoids
Immunosuppressive Agents
Antilymphocyte Serum
Multiple Sclerosis
Mental Disorders
Demyelinating Autoimmune Diseases, CNS
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Hormones
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Alkylating Agents
Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Sclerosis
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Antilymphocyte Serum
Myeloablative Agonists
Demyelinating Autoimmune Diseases, CNS
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 06, 2009