Phase II Trial in Intrafamilial Allogeneic Cell Transplant in Patients With Metastatic Kidney Cancer
- 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
- 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.
PROJECTED ACCRUAL: A total of 170 patients (60 patients for group I and 110 patients for
group II) will be accrued for this study within 3 years.
Allocation: Non-Randomized, Primary Purpose: Treatment
Survival rate at 18 months
Didier Blaise, MD