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

NCT00014755 | Completed Phase 1

• 2 other identifiers: 199/15796FHCRC-1164.00
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; neurologic and psychiatric disorders; rare disease

Interventions

anti-thymocyte globulin DRUG

cyclophosphamide DRUG

filgrastim DRUG

prednisone DRUG

peripheral blood stem cell transplantation PROCEDURE

irradiation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (6)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80262, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 22056644 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Neurologic Manifestations; Mental Disorders; Rare Diseases

Interventions

Antilymphocyte Serum; Cyclophosphamide; Filgrastim; Prednisone; Peripheral Blood Stem Cell Transplantation; Radiation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Physical Phenomena

Study Officials

• Richard Nash

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: April 11, 2001
• Study Start: December 1, 1997
• Last Updated: June 24, 2005

Record last verified: 2001-04

Locations

US (6)