Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation With T Lymphocyte-Depleted Autologous Peripheral Blood Stem Cell or Bone Marrow Rescue in Patients With Multiple Sclerosis
Multiple Sclerosis

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, neurologic and psychiatric disorders, rare disease
Eligibility Criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of multiple sclerosis Kurtzke score of 4.0-7.5 Increase of 1.0 point over the past 12 months More than 3 relapses in 24 months despite conventional disease modifying therapy Failure to stabilize active clinical progression with a 3-day regimen of methylprednisolone IV --Prior/Concurrent Therapy-- Chemotherapy: No prior cladribine Radiotherapy: No prior radiotherapy to greater than 10 cm2 of lung tissue No prior craniospinal irradiation No prior total lymphoid irradiation --Patient Characteristics-- Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Hepatitis B antigen negative Bilirubin no greater than 2.0 mg/dL Transaminases no greater than 2 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of coronary artery disease Resting LVEF at least 45% Pulmonary: FEV1/FVC at least 75% predicted DLCO at least 50% predicted Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No other concurrent medical illness that would preclude study No concurrent psychiatric illness or mental deficiency that would preclude study No prior malignancy except localized basal cell or squamous cell skin cancer (malignancies judged to be cured by local surgical therapy such as head and neck cancer or stage I breast cancer, are considered on an individual basis) No presence of body shrapnel, metal fragments, or unremovable devices such as a pacemaker or aneurysm clip
Sites / Locations
- Northwestern Memorial Hospital
- Rush-Presbyterian-St. Luke's Medical Center