Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer

OBJECTIVES:

• Determine the 18-month survival rate of patients with metastatic renal cell carcinoma treated with allogeneic stem cell transplantation.
• Determine the objective rate of response of patients treated with this regimen.
• Determine post-transplant immunological reactions and recuperation of patients treated with this regimen.
• Determine the antitumoral activity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups based on availability of a compatible family member for stem cell transplantation.

• Group I: Patients with a compatible family donor receive conditioning chemotherapy comprising cyclophosphamide IV over 2 hours on days -7 and -6 and fludarabine IV once daily on days -5 to -1. Patients undergo filgrastim (G-CSF)-mobilized allogeneic stem cell transplantation on day 0. Patients also receive immunosuppression therapy with cyclosporine beginning on day -2. Patients who have persistent or progressive disease, mixed chimerism, and no evidence of grade 2 or greater graft-vs-host disease, and have been off immunosuppression therapy for 1-2 weeks receive donor lymphocyte infusion on days 7 and 21.
• Group II: Patients without a compatible family donor receive treatment (immunotherapy, vaccination therapy, or chemotherapy) at the discretion of the treating physician.

Patients are followed every 3 months for 5 years.