Kidney Cancer Clinical Trial
Official title:
Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma
RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or
sister may be an effective treatment for kidney cancer.
PURPOSE: This phase II trial is studying how well a donor peripheral stem cell or bone
marrow transplant works in treating patients with relapsed or refractory metastatic kidney
cancer.
OBJECTIVES:
- Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem
cell transplantation in patients with relapsed or refractory metastatic renal cell
carcinoma.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study.
- Conditioning regimen: Patients receive cyclophosphamide IV on days -7 and -6 and
fludarabine IV on days -5 to -1. Patients receiving 5/6-mismatched cells also receive
anti-thymocyte globulin IV on days -5 to -3.
- Allogeneic peripheral blood stem cell (PBSC) infusion: Patients undergo allogeneic PBSC
or bone marrow transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive oral mycophenolate
mofetil twice daily on days 0-30. Patients receive tacrolimus IV continuously or orally
twice daily beginning on day -2 and continuing up to day 44-100 in the absence of GVHD.
- Donor lymphocyte infusion: Patients with partial or complete T-cell chimerism receive
up to 3 donor lymphocyte infusions in the absence of GVHD or progressive disease.
After completion of study treatment, patients are evaluated periodically for 3 years.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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