Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Metastatic Renal Cell Carcinoma
OBJECTIVES:
- Determine the efficacy of nonmyeloablative conditioning comprising fludarabine and
total-body irradiation followed by allogeneic hematopoietic stem cell transplantation,
in terms of 6-month and 12-month response rate, in patients with unresectable
metastatic renal cell carcinoma.
OUTLINE:
- Nonmyeloablative conditioning regimen: Patients receive fludarabine IV on days -4 to -2
and total-body irradiation (TBI) on day 0.
- Allogeneic hematopoietic stem cell transplantation (AHSCT): After TBI, patients undergo
AHSCT on day 0.
- Immunosuppression: Patients receive oral cyclosporine twice daily on days -3 to 56
followed by a taper until day 81. Patients also receive oral mycophenolate mofetil
twice daily on days 0-27 (if patient has a related donor) OR three times daily on days
0-29 and then twice daily on days 30-149 followed by additional tapering until day 180
(if patient has an unrelated donor).
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete and partial response) at 6 and 12 months after transplantation
No
Brandon M. Hayes-Lattin, MD
Study Chair
OHSU Knight Cancer Institute
United States: Federal Government
CDR0000447207
NCT00243009
June 2005
April 2006
Name | Location |
---|---|
OHSU Knight Cancer Institute | Portland, Oregon 97239 |