Status:
WITHDRAWN
Phase II High-Dose Cyclophosphamide for Multiple Sclerosis
Lead Sponsor:
Stony Brook University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 di...
Detailed Description
Multiple sclerosis (MS) is the major disabling neurologic disease of young adults,and represents the most common immune-mediated inflammatory and demyelinating disorder of the central nervous system (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00296205
Start Date
October 1 2003
End Date
February 1 2006
Last Update
July 22 2009
Active Locations (1)
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1
Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8174