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RATIONALE: Giving different schedules of mycophenolate mofetil and cyclosporine may be effective in reducing graft-versus-host disease in patients undergoing donor peripheral stem cell transplantation for hematologic malignancies (cancer) and metastatic renal cell carcinoma.
PURPOSE: This phase I/II trial is studying the side effects and best way to give mycophenolate mofetil and cyclosporine and to see how well they work in reducing graft-versus-host disease in treating patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer or metastatic renal cell carcinoma.
- Determine whether the incidence of life-threatening graft-versus-host disease (GVHD) can be reduced after unrelated donor peripheral blood mononuclear cell hematopoietic stem cell transplantation using nonmyeloablative conditioning with truncated cyclosporine and prolonged administration of mycophenolate mofetil in patients with hematologic malignancies or metastatic renal cell carcinoma.
- Compare the incidence of acute and chronic GVHD in patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00.
- Compare the utilization of corticosteroids in patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00.
- Compare the survival of patients treated with this regimen vs patients treated on protocols FHCRC-1463.00 and FHCRC-1641.00.
OUTLINE: This is a multicenter study.
- Conditioning regimen: Patients receive fludarabine IV over 30 minutes on days -4 to -2 and low-dose total body irradiation (TBI) on day 0.
- Allogeneic hematopoietic stem cell transplantation (HSCT): After the completion of TBI, patients undergo allogeneic HSCT on day 0.
- Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 80 in the absence of acute graft-versus-host disease (GVHD). Patients also receive oral mycophenolate mofetil (MMF) 3 times daily on days 0-29 and then, in the absence of GVHD, twice daily on days 30-149. MMF is tapered beginning on day 150 and continuing until day 180.
Patients are followed at 6 months, 12 months, 18 months, and 24 months and then annually for 5 years after HSCT.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1.5 years.
Masking: Open Label, Primary Purpose: Supportive Care
Chronic Myeloproliferative Disorders
graft-versus-tumor induction therapy, cyclosporine, fludarabine phosphate, mycophenolate mofetil, peripheral blood stem cell transplantation, radiation therapy
Stanford Cancer Center at Stanford University Medical Center
Active, not recruiting
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:54:32-0400
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It a...
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RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth ...
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The induction of prolonged survival and growth of allografts of either tumors or normal tissues which would ordinarily be rejected. It may be induced passively by introducing graft-specific antibodies from previously immunized donors, which bind to the graft's surface antigens, masking them from recognition by T-cells; or actively by prior immunization of the recipient with graft antigens which evoke specific antibodies and form antigen-antibody complexes which bind to the antigen receptor sites of the T-cells and block their cytotoxic activity.
A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).
Immunological rejection of tumor tissue/cells following bone marrow transplantation.
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