Phase II High-Dose Cyclophosphamide for Multiple Sclerosis

• Status: Withdrawn
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Treatments: Cyclophosphamide

Criteria

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