Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Toxicity as measured by NCI CTC at days 0, 7, 14, 21 and 28 after transplantation and monthly for 11 months
• Overall and disease-free survival at day 100 and 1 year after transplantation