Trial Information

Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma

OBJECTIVES:

- Determine the duration and efficiency of hematopoietic and immunologic engraftment in
patients with advanced renal cell carcinoma treated with pentostatin followed by
related allogeneic stem cell transplantation.

- Determine the hematologic and non-hematologic toxic effects of this regimen in these
patients.

- Determine the incidence and severity of graft-versus-host disease in patients treated
with this regimen.

OUTLINE: This is a dose-escalation study of pentostatin.

- Phase I: Patients receive pentostatin IV on days -7, -5, and -3 followed by allogeneic
stem cell transplantation on day 0. Beginning on day 1, patients receive filgrastim
(G-CSF) IV over 1 hour or subcutaneously daily until blood counts recover. As
graft-versus-host disease prophylaxis, patients receive cyclosporine IV continuously
until stem cell engraftment and then orally with gradual tapering.

Cohorts of 3 to 6 patients receive escalating doses of pentostatin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients
experience dose-limiting toxicity.

- Phase II: Patients receive treatment as in phase I at the MTD for pentostatin. Patients
are followed weekly for 60 days and then monthly for 10 months.

PROJECTED ACCRUAL: A total of 24 patients (12 per phase) will be accrued for this study.