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 - Full Text View

Sponsor:	Northwestern Memorial Hospital
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00017628

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: cyclophosphamide Drug: filgrastim Drug: methylprednisolone Procedure: Autologous Stem Cell Transplantation	Phase I

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Cyclophosphamide Methylprednisolone Filgrastim

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	20
Study Start Date:	April 2001

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.

Eligibility

Ages Eligible for Study:	up to 59 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017628

Locations

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Northwestern Memorial Hospital

Investigators

Study Chair:

Richard K. Burt

Northwestern Memorial Hospital

More Information

No publications provided

Study ID Numbers:	199/14975, NU-95MS1
Study First Received:	June 6, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00017628 History of Changes
Health Authority:	Unspecified

Keywords provided by Office of Rare Diseases (ORD):

multiple sclerosis
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Cyclophosphamide
Hormones
Neuroprotective Agents
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses

Alkylating Agents
Autoimmune Diseases of the Nervous System
Methylprednisolone Hemisuccinate
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Sclerosis
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 09, 2009