Kidney Cancer Clinical Trial
Official title:
Non-Myeloablative Chemotherapy Followed By Related Allogeneic Stem Cell Rescue In Patients With Advanced Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with donor peripheral stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of pentostatin followed by peripheral
stem cell transplantation in treating patients who have advanced kidney cancer.
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.
;
Primary Purpose: Treatment
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