Multiple Sclerosis Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00014755

Recruitment Status:

Completed

Sponsor:

Fred Hutchinson Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 6 Locations for this study

See Locations Near You

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, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

35

Study ID:

NCT00014755

Recruitment Status:

Completed

Sponsor:


Fred Hutchinson Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider