Phase II High-Dose Cyclophosphamide for Multiple Sclerosis

Treatment tested

• Cyclophosphamide anhydrous

Other measures (1)

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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.