Non-Myeloablative HLA-Matched Sibling Allogeneic Peripheral Blood Stem Cell Transplantation for Metastatic Renal Cell Carcinoma
- Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem
cell transplantation in patients with relapsed or refractory metastatic renal cell
- 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
Response rate based on tumor measurements at 1 year
J. J. Ifthikharuddin, MD
James P. Wilmot Cancer Center
United States: Federal Government
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|