High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis

NCT00040482 | Completed Phase 2

• 2 other identifiers: H7156Multiple Sclerosis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis is a disease that may be caused by the immune system reacting against the nervous system. It is possible, that by changing the immune system we can modify the progression of this disease. In this study, we will try to learn whether treatment with a bone marrow transplant (BMT) can help patients with multiple sclerosis. We will also try to learn what the side effects are of this treatment in patients with multiple sclerosis.

Conditions

Multiple Sclerosis

Interventions

Cyclophosphamide DRUG

ATG DRUG

MESNA DRUG

Radiation therapy PROCEDURE

Eligibility Criteria

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

You may qualify if:

• The diagnosis of primary or secondary progressive multiple sclerosis or relapsing-remitting multiple sclerosis. Patients with relapsing/remitting MS should demonstrate sustained accumulated disability based upon accepted standard. Relapsing/remitting MS is characterized by unpredictable recurrent attacks of neurologic dysfunction followed by complete, partial or no recovery.
• By the Expanded Disability Status Scale (EDSS) the measure of disability equals or exceeds 5.0 but does not exceed 7.5.
• For primary or secondary progressive MS, the progression of disease using EDSS criteria during the proceeding 12 months equals or exceeds 1.0.
• Symptoms and manifestations of MS activity have not responded to conventional treatment, e.g. high dose prednisone, beta interferon, conventional dose cytoxan, glatiramer acetate etc.
• The patient is able to undergo collection of sufficient numbers of HSCs to meet protocol requirements, i.e. 3X10e6 CD34+ cells.
• Males and females \<60 years old.
• Patient must have a life expectance of \>6 weeks.
• Patients should not have received prior lymphoid irradiation.
• Patients should not have a history of hypersensitivity to murine proteins or E.coli derived proteins.
• Patients should not have a history of lack of compliance with medical care or any medical or psychiatric conditions which would compromise their ability to comply with the protocol.
• Patients should not have evidence of myelodysplasia or an active malignancy.
• Patients should not be receiving concurrent beta interferon therapy or high dose prednisone.
• The patient does not exhibit significant organ toxicity from any cause. Significant organ toxicity includes:- Creatinine greater than twice normal; glomerular filtration rate less than 40 ml/min. - FEV1 or FVC less than 75% predicted; DLCO less than 50% predicted.- Significant cardiac dysfunction defined as life endangering arrythmias or a shortened ejection fraction(less than 26%).- Hepatic transaminases greater than two times normal; total bilirubin greater than 3.0 mg/dl.
• The patients are able to give informed consent.
• Both male and female patients must agree to use effective contraception for a minimum of 12 months post transplant. Effective contraception includes total abstinence, oral contraceptives, an intrauterine device, contraceptive implants under the skin (Norplants), contraceptive injections, or contraceptive foam with a condom. In addition, the male partner should use a condom.

You may not qualify if:

• Active infection.
• Unable to tolerate an MRI.
• HIV positive patient.
• Pregnant and lactating women

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator
• Center for Cell and Gene Therapy, Baylor College of Medicine: collaborator

Study Sites (1)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cyclophosphamide; Mesna; Radiotherapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Therapeutics

Study Officials

• Malcolm K. Brenner, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics-Hem-Onc Cell & Gene

Study Record Dates

• First Submitted: June 26, 2002
• First Posted: June 28, 2002
• Study Start: April 1, 1999
• Study Completion: August 1, 2005
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)