Multiple SclerosisPhase 1NCT00017628
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
A Phase 1 study testing cyclophosphamide, filgrastim and methylprednisolone in people with Multiple Sclerosis, run by Northwestern Memorial Hospital at 2 sites in United States.
Trial summary
OBJECTIVES: I. Determine the efficacy, in terms of disease progression, 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. Read more about this study
- Who is it for?
- Ages 0 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cyclophosphamide, filgrastim and methylprednisolone
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2001to not given
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 59 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
About this study
OBJECTIVES:
- Determine the efficacy, in terms of disease progression, 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.
Read the detailed description
PROTOCOL OUTLINE: Following an induction course of cyclophosphamide IV, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Harvested PBSCs or bone marrow then undergo T-lymphocyte depletion.
Patients receive cyclophosphamide IV over 1 hour on days -6 and -5 and methylprednisolone IV daily on days -4 to -1. Patients also undergo total body irradiation twice a day on days -4 to -1. Lymphocyte-depleted PBSCs or bone marrow is reinfused on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts have recovered for 3 days.
Patients are followed at 1, 2, 3, 6, and 12 months and then annually for 5 years.
- Conditions
- Multiple Sclerosis
- Being tested
- cyclophosphamide, filgrastim, methylprednisolone, Autologous Stem Cell Transplantation
- Keywords
- multiple sclerosis, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Multiple Sclerosis, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
filgrastimDrug
Autologous Stem Cell TransplantationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2001 (estimated)
- Study startApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Northwestern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Richard K. Burt, Study chair, Northwestern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017628
- Sponsor's protocol ID
- 199/14975
- Other IDs
- NU-95MS1
- Status last verified
- Jul 2004
- First submitted
- 6 Jun 2001
- Last updated
- 24 Jun 2005
- Results posted
- No