Status:
TERMINATED
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
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 sy...
Detailed 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-m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00243009
Start Date
June 1 2005
End Date
April 1 2006
Last Update
May 28 2012
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098