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Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
filgrastim
methylprednisolone
Autologous Stem Cell Transplantation
Sponsored by
Northwestern Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

0 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of multiple sclerosis Kurtzke score of 4.0-7.5 Increase of 1.0 point over the past 12 months More than 3 relapses in 24 months despite conventional disease modifying therapy Failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone IV --Prior/Concurrent Therapy-- Chemotherapy: No prior cladribine Radiotherapy: No prior radiotherapy to greater than 10 cm2 of lung tissue No prior craniospinal irradiation No prior total lymphoid irradiation --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Hepatitis B antigen negative Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of coronary artery disease Resting LVEF at least 45% Pulmonary: FEV1/FVC at least 75% predicted DLCO at least 50% predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No other concurrent medical illness that would preclude study No concurrent psychiatric illness or mental deficiency that would preclude study No prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage I breast cancer, are considered on an individual basis) No presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip

Sites / Locations

  • Northwestern Memorial Hospital
  • Rush-Presbyterian-St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
June 23, 2005
Sponsor
Northwestern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00017628
Brief Title
Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern Memorial Hospital

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Determine the efficacy, in terms of disease progression, of high-dose cyclophosphamide and total body irradiation with T lymphocyte-depleted autologous peripheral blood stem cell or bone marrow rescue in patients with multiple sclerosis.
Detailed Description
PROTOCOL OUTLINE: Following an induction course of cyclophosphamide IV, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Harvested PBSCs or bone marrow then undergo T-lymphocyte depletion. Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV daily on days -4 to -1. Patients also undergo total body irradiation twice a day on days -4 to -1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days. Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, neurologic and psychiatric disorders, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Procedure
Intervention Name(s)
Autologous Stem Cell Transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of multiple sclerosis Kurtzke score of 4.0-7.5 Increase of 1.0 point over the past 12 months More than 3 relapses in 24 months despite conventional disease modifying therapy Failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone IV --Prior/Concurrent Therapy-- Chemotherapy: No prior cladribine Radiotherapy: No prior radiotherapy to greater than 10 cm2 of lung tissue No prior craniospinal irradiation No prior total lymphoid irradiation --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Hepatitis B antigen negative Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of coronary artery disease Resting LVEF at least 45% Pulmonary: FEV1/FVC at least 75% predicted DLCO at least 50% predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No other concurrent medical illness that would preclude study No concurrent psychiatric illness or mental deficiency that would preclude study No prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage I breast cancer, are considered on an individual basis) No presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard K. Burt
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis

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