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

Inclusion 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