Kidney Cancer Clinical Trial
Official title:
Allogeneic Adoptive Immunochemotherapy For Treatment Of Renal Cell Carcinoma
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, use
different ways to stop cancer cells from dividing so they stop growing or die. Peripheral
stem cell transplantation may be able to replace immune cells that were destroyed by
chemotherapy. Sometimes the transplanted cells can reject the body's normal tissues.
Alemtuzumab and tacrolimus may prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combining fludarabine and
cyclophosphamide with alemtuzumab in treating patients who are undergoing allogeneic stem
cell transplantation for recurrent or metastatic renal cell carcinoma (kidney cancer).
OBJECTIVES:
- Determine the safety and feasibility of fludarabine, cyclophosphamide, and alemtuzumab
in patients with recurrent or metastatic renal cell carcinoma undergoing HLA-matched
allogeneic stem cell transplantation.
OUTLINE: This is a pilot, multicenter study.
- Conditioning: Patients receive fludarabine IV over 30 minutes on days -6 to -2,
cyclophosphamide IV over 2 hours on days -6 and -5, and alemtuzumab IV on days -4 to
-2.
- Allogeneic transplantation: Allogeneic stem cells are infused on day 0. Patients
receive graft-vs-host disease prophylaxis with tacrolimus IV or orally for
approximately 30 days.
Patients are followed weekly for 100 days and then at 6, 12, 18, 24, 36, 48, and 60 months
after transplantation.
PROJECTED ACCRUAL: A total of 20 patients (10 with HLA-identical related donors and 10 with
matched unrelated donors) will be accrued for this study.
;
Primary Purpose: Treatment
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