Phase II High-Dose Cyclophosphamide for Multiple Sclerosis
Withdrawn before enrolling · Phase 2
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00296205
- Run by
- Stony Brook University
- People needed
- 25
- Starts
- 2003-10-01
- Expected to finish
- 2006-02-01
- Last updated by the study team
- 2009-07-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Stony Brook University Hospital — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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