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Investigator(s):
Daniel Fowler, M.D. Principal Investigator Phone: 301-435-8641 dhfowler@helix.nih.gov
Referral Contact(s):
Mike Krumlauf, R.N., B.S.N., O.C.N. Research Nurse Phone: 301-594-2056 Fax: 301-435-6830 krumlaum@mail.nih.gov

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Primary Eligibility:

• Diagnosis of metastatic renal cell carcinoma
• Pure clear cell type or predominant clear cell type with features of mixed differentiation
• Prior nephrectomy (either partial or complete resection)
• Progressive disease after prior treatment with sorafenib, sunitinib, or temsirolimus
• Patients eligible for high-dose interleukin-2 (IL-2) and who elect to receive this therapy must have progressive disease after treatment with IL-2 AND must also have progressive disease after treatment with sorafenib, sunitinib, or temsirolimus
• No active CNS involvement
• 6/6 HLA-matched (A, B, DR) sibling donor available
• Karnofsky performance status 80–100%
• Left ventricular ejection fraction > 40% by MUGA or ECHO
• DLCO > 50% of expected value (hemoglobin corrected)
• Creatinine clearance ≥ 40 mL/min
• Total bilirubin < 2.5 mg /dL
• Serum ALT and AST ≤ 2.5 x upper limit of normal (ULN) (5 x ULN if due to liver involvement)
• Not pregnant or nursing; fertile patients must use effective contraception during and for at least 1 year after transplantation
• No active infection that does not respond to antimicrobial therapy
• No HIV infection
• No chronic active hepatitis B
• Hepatitis B core antibody positive allowed
• No history of psychiatric disorder that would preclude compliance with study or that would preclude giving informed consent

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Treatment Plan:

This is a multicenter study.

• Induction therapy:
• Patients receive oral cyclophosphamide once daily on Days 1–21 and pentostatin IV on Days 1, 8, and 15


• Allogeneic hematopoietic stem cell transplantation:
• Patients receive allogeneic peripheral blood stem cells IV on Day 24; patients also receive filgrastim (G-CSF) subcutaneously beginning on Day 24 and continuing until blood counts recover


• Graft-versus-host disease prophylaxis:
• Patients receive high-dose oral sirolimus on Days 22–84


• Donor lymphocyte infusions:
• Patients receive donor Th2 cells IV on Days 24, 38, and 69


• After completion of therapy, patients are followed periodically for at least 5 years

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 7/7/08
Updated: 4/29/08