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Immunosuppression With Mycophenolate Mofetil and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Donor Peripheral Stem Cell Transplantation for Hematologic Malignancies or Metastatic Renal Cell Carcinoma

2014-08-27 03:54:32 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- 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.

Secondary

- 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.

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Conditions

Chronic Myeloproliferative Disorders

Intervention

graft-versus-tumor induction therapy, cyclosporine, fludarabine phosphate, mycophenolate mofetil, peripheral blood stem cell transplantation, radiation therapy

Location

Stanford Cancer Center at Stanford University Medical Center
Stanford
California
United States
94305-5623

Status

Active, not recruiting

Source

Fred Hutchinson Cancer Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:32-0400

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A Mesenchymal Stromal Cell (MSC)-Derived Combination of CXCL5 and Anti-CCL24 is Synergistic and Superior to MSC and Cyclosporine for the Treatment of Graft-Versus-Host Disease.

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Medical and Biotech [MESH] Definitions

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.

Immunized T-lymphocytes which can directly destroy appropriate target cells. These cytotoxic lymphocytes may be generated in vitro in mixed lymphocyte cultures (MLC), in vivo during a graft-versus-host (GVH) reaction, or after immunization with an allograft, tumor cell or virally transformed or chemically modified target cell. The lytic phenomenon is sometimes referred to as cell-mediated lympholysis (CML). These CD8-positive cells are distinct from NATURAL KILLER CELLS and NATURAL KILLER T-CELLS. There are two effector phenotypes: TC1 and TC2.

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

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