Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment of the donor bone marrow with the patient's white blood cells and a monoclonal antibody may prevent this from happening.
PURPOSE: Phase I trial to study the effectiveness of bone marrow transplantation with specially treated bone marrow in treating patients who have hematologic cancer that has not responded to previous therapy.
|Graft Versus Host Disease Leukemia Lymphoma Myelodysplastic Syndromes Myeloma||Drug: cyclophosphamide Drug: cyclosporine Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Procedure: in vitro-treated bone marrow transplantation Radiation: radiation therapy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Open-Label, Safety Study of Haploidentical Bone Marrow Transplantation (BMT) After Ex Vivo Treatment of Bone Marrow With Anti-B7.1 and Anti-B7.2 Antibodies|
- Incidence of primary graft failure [ Time Frame: up to 30 days post-transplant ]
- Incidence of hyperacute GVHD [ Time Frame: up to 100 days post-transplant ]
- Incidence of Grade D acute GVHD [ Time Frame: up to 50 days post-transplant ]
- Incidence of adverse events [ Time Frame: up to 100 days post-transplant ]
|Actual Study Start Date:||February 2000|
|Study Completion Date:||March 8, 2002|
|Primary Completion Date:||June 16, 2001 (Final data collection date for primary outcome measure)|
Experimental: in vitro-treated bone marrow transplantation
||Drug: cyclophosphamide Drug: cyclosporine Drug: leucovorin calcium Drug: methotrexate Drug: methylprednisolone Procedure: in vitro-treated bone marrow transplantation Radiation: radiation therapy|
OBJECTIVES: I. Determine if patients with refractory, high risk hematologic malignancies or bone marrow failure who receive HLA haploidentical bone marrow treated with anti-B7 antibody have normal engraftment. II. Determine if these patients are free of hyperacute graft versus host disease (GVHD), defined as grade D GVHD in the first 10 posttransplant days, when treated with this regimen. III. Determine if these patients have an acceptable incidence of life threatening grade D GHVD in the first 50 posttransplant days following this treatment regimen. IV. Determine the safety and tolerability of this treatment regimen in this patient population.
OUTLINE: This is a multicenter study. Patients undergo leukapheresis to collect white blood cells which are incubated with donor bone marrow cells in the presence of anti-B7.1 and anti-B7.2 antibodies for 36 hours. Patients receive total body irradiation twice daily on days -6 to -3, cyclophosphamide IV daily on days -2 and -1, and methylprednisolone IV every 12 hours for a total of 4 doses on days -2 to 0. Patients are infused with the treated donor bone marrow on day 0. Patients then receive methotrexate IV on days 1, 3, 6, and 11 and leucovorin calcium IV 24 hours after each dose of methotrexate every 6 hours for 3-8 doses each time. Patients also receive cyclosporine IV or orally twice daily on days -2 to 100. Patients are followed every 2 months for 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005988
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|University of Minnesota Cancer Center|
|Minneapolis, Minnesota, United States, 55455|
|Study Chair:||Eva Guinan, MD||Dana-Farber Cancer Institute|