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Phase 1
18 Years
60 Years
Not Enrolling
Both
Multiple Sclerosis

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Trial Information


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard Nash

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

Unspecified

Study ID:

199/15796

NCT ID:

NCT00014755

Start Date:

December 1997

Completion Date:

Related Keywords:

  • Multiple Sclerosis
  • multiple sclerosis
  • neurologic and psychiatric disorders
  • rare disease
  • Multiple Sclerosis
  • Sclerosis

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Colorado Cancer CenterDenver, Colorado  80262
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Washington University Barnard Cancer CenterSaint Louis, Missouri  63110
City of Hope National Medical CenterLos Angeles, California  91010
Duke University Medical CenterDurham, North Carolina  27710