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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

Information source: Office of Rare Diseases (ORD)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: anti-thymocyte globulin (Drug); cyclophosphamide (Drug); filgrastim (Drug); prednisone (Drug); peripheral blood stem cell transplantation (Procedure); irradiation (Procedure)

Phase: Phase 1

Status: Completed

Sponsored by: Fred Hutchinson Cancer Research Center

Official(s) and/or principal investigator(s):
Richard Nash, Study Chair, Affiliation: Fred Hutchinson Cancer Research Center

Summary

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.

Clinical Details

Study design: Primary Purpose: Treatment

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

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

City of Hope National Medical Center, Duarte, California 91010, United States

University of Colorado Cancer Center, Denver, Colorado 80262, United States

Washington University Barnard Cancer Center, Saint Louis, Missouri 63110, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Fred Hutchinson Cancer Research Center, Seattle, Washington 98109, United States

Additional Information

Starting date: December 1997
Last updated: June 23, 2005

Page last updated: August 20, 2015

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