Last Verified: | January/31/2020 |
First Submitted: | March/5/2003 |
Estimated Enrollment Submitted: | March/5/2003 |
First Posted: | March/6/2003 |
Last Update Submitted: | February/17/2020 |
Last Update Posted: | February/19/2020 |
Actual Study Start Date: | November/3/2002 |
Estimated Primary Completion Date: | February/12/2008 |
Estimated Study Completion Date: | February/12/2008 |
Study Type: | Interventional |
Allocation: | Non-Randomized |
Primary Purpose: | Treatment |
Masking: | None (Open Label) |
Arm | Intervention/treatment |
---|---|
Experimental: Allograft (compatible family member) | Biological: Allograft (compatible family member) |
Other: Allograft (compatible non-family member) |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | DISEASE CHARACTERISTICS: - Histologically confirmed metastatic renal cell carcinoma - No sarcomatoid, pure papillary, or Bellini renal cell cancer - Measurable and/or evaluable disease - Disease progression after at least 1 immunotherapy regimen for metastatic disease - Localized metastases allowed provided the following are true: - At least 3 months since prior treatment for metastases - Not considered likely to influence outcome of transplantation - No brain metastases unless treated surgically or radiologically and MRI normal - Sufficiently healthy, HLA-compatible family member must be available as donor for patients undergoing stem cell transplantation PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - ECOG 0-1 Life expectancy - More than 6 months Hematopoietic - Platelet count at least 100,000/mm^3 Hepatic - Transaminases less than 1.5 times upper limit of normal (ULN)* - Bilirubin less than 1.5 times ULN* NOTE: *Unless due to Gilbert's disease Renal - No renal insufficiency - Calcium less than 10.4 mg/dL - Creatinine clearance greater than 50 mL/min Cardiovascular - Ejection fraction greater than 50% Pulmonary - No DLCO that would preclude fludarabine or busulfan therapy Other - Not pregnant or nursing - Fertile patients must use effective contraception - No physical obstacle to receiving study treatment - No known autoimmune disease - No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix - No uncontrolled bacterial, viral, or fungal infection - No prior or concurrent psychiatric disease - HIV negative - HTLV1 negative PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - No tolerance to fludarabine and busulfan Endocrine therapy - No concurrent corticosteroids Radiotherapy - Not specified Surgery - Not specified |