Status:
COMPLETED
Donor Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Relapsed or Refractory Metastatic Kidney Cancer
Lead Sponsor:
University of Rochester
Conditions:
Kidney Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
RATIONALE: A peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer. PURPOSE: This phase II trial is studying how well a do...
Detailed Description
OBJECTIVES: * Determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma. * Deter...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma
- Relapsed or refractory disease
- Tumor not amenable to complete surgical resection
- No bone metastases only
- No untreated brain metastases
- Measurable disease
- Available sibling donor who is HLA-identical or who has a mismatch at a single HLA locus (i.e., a 6/6 or 5/6 match at the HLA-A, -B, and -DR loci)
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin \< 3 mg/dL
- Renal
- Creatinine \< 2 mg/dL
- No untreated hypercalcemia
- Cardiovascular
- LVEF ≥ 40%
- Pulmonary
- DLCO ≥ 40%
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test
- HIV-1 and -2 negative
- No uncontrolled infection
- No other active malignancy except basal skin cancer or carcinoma in situ of the cervix
- PRIOR CONCURRENT THERAPY:
- At least 15 days since prior treatment for renal cell carcinoma
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00262886
Start Date
August 1 2001
Last Update
June 6 2013
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642