Phase II High-Dose Cyclophosphamide for Multiple Sclerosis

NCT00296205 | Withdrawn Phase 2

• 1 other identifier: 20055203
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what percentage of patients receiving high-dose Cyclophosphamide may experience a halt in the worsening of their disease or experience improvement of their disease and for how long the benefit may last.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Cyclophosphamide; autoimmune

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is to evaluate the response rate of MS patients after high-dose cyclophosphamide therapy as determined by a sustained (greater than 6 months) decrease of greater than or equal to 1.0 in their EDSS score.

Secondary Outcomes (1)

• The secondary endpoint of this study is to evaluate time to EDSS score progression.

Interventions

Cyclophosphamide DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of secondary progressive (SPMS), primary progressive (PPMS) or progressive relapsing (PRMS) multiple sclerosis
• A diagnosis of MS will be established by fulfilling criteria "Recommended Diagnostic Criteria for Multiple Sclerosis: Guidelines from the Internal Panel on the Diagnosis of Multiple Sclerosis"
• The subtype of MS will be established by the natural history of the disease
• Age \>18 but \< 75 years
• An extended disability status scale (EDSS) score of \>3.5 after two standard treatment regimens IFNB1a IFNB1b Glatiramer acetate Mitoxanthrone Steroids, plasmapheresis or IVIG individually or in combination constitute a single treatment regimen
• Patient must have a left ventricular ejection fraction of \> 45%
• Serum Creatinine \<3mg/dL
• For women of childbearing potential, serum βHCG (less than seven days before start of cyclophosphamide)
• Willingness to participate in a clinical trial

You may not qualify if:

• Patients who are preterminal or moribund
• Patients with active malignancies
• Patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome
• Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection
• Pregnant women and breast-feeding women
• Patients with known intolerance to G-CSF

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794-8174, United States

Location

Related Publications (1)

• Gladstone DE, Zamkoff KW, Krupp L, Peyster R, Sibony P, Christodoulou C, Locher E, Coyle PK. High-dose cyclophosphamide for moderate to severe refractory multiple sclerosis. Arch Neurol. 2006 Oct;63(10):1388-93. doi: 10.1001/archneur.63.10.noc60076. Epub 2006 Aug 14.

  PMID: 16908728 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cyclophosphamide

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

Study Officials

• Douglas E Gladstone, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 23, 2006
• First Posted: February 24, 2006
• Study Start: October 1, 2003
• Study Completion: February 1, 2006
• Last Updated: July 22, 2009

Record last verified: 2006-10

Locations

US (1)