Kidney Cancer Clinical Trial
Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery
Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with total-body irradiation works in treating patients who are undergoing a donor stem cell transplant for metastatic kidney cancer that cannot be removed by surgery.
Full Description
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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma, including 1 of the following subtypes:
Clear cell
Papillary
Medullary
Metastatic disease
Not amenable to curative surgery
No CNS metastases
PATIENT CHARACTERISTICS:
Performance status
Karnofsky 70-100%
Life expectancy
More than 6 months
Hematopoietic
Not specified
Hepatic
Bilirubin < 2 times upper limit of normal (ULN)
AST or ALT < 4 times ULN
Renal
Creatinine clearance > 50 mL/min
Cardiovascular
LVEF > 35%
No symptomatic congestive heart failure
Pulmonary
DLCO > 40% of predicted OR
Total lung capacity or FEV_1 > 30% of predicted
PRIOR CONCURRENT THERAPY:
Biologic therapy
More than 30 days since prior biologic therapy
Chemotherapy
More than 30 days since prior chemotherapy
Radiotherapy
More than 30 days since prior radiotherapy
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There is 1 Location for this study
Portland Oregon, 97239, United States
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