Phase I Study of High-Dose Cyclophosphamide and Total Body Irradiation
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
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Cyclophosphamide anhydrous
- Filgrastim
Granulocyte colony stimulating factor receptor agonist
- Methylprednisolone
Glucocorticoid receptor agonist
- Autologous Stem Cell Transplantation
Who could take part
MS (type not specified) · 0 to 59
Show the full criteria
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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Scle
Phase 4 · Status unknown
No results found
- A phase IV, unicentric, open label clinical trial to evaluate the defa
Phase 4 · Withdrawn
Stopped
- Effects of a Multiple Sclerosis Relapse Therapy on Offspring Neurocogn
Status unknown
Paper found, not read
- AHSCT With Fludarabine and Cyclophosphamide Based Conditioning Regimes
Phase 1 · Recruiting
Still running
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown
No results found
- Physical and Cognitive Performance During the Two First Years of Lemtr
Completed
Paper found, not read
History
Started
Apr 2001