• Disease response [ Designated as safety issue: No ]
  
• Safety as measured by transplant related mortality on day 200 after allografting [ Designated as safety issue: Yes ]
  
• Donor engraftment on day 56 after allografting [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine if mixed or full donor hematopoietic chimerism can be safely achieved with nonmyeloablative conditioning therapy in patients with metastatic renal cell carcinoma.
• Determine if mixed chimerism can be safely converted to full donor hematopoietic chimerism with donor lymphocyte infusions in this patient population.
• Determine the efficacy of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive fludarabine IV on days -4 to -2 and undergo total body irradiation followed by filgrastim (G-CSF)-mobilized HLA-matched allogeneic peripheral blood stem cell transplantation on day 0.

Patients receive immunosuppressive therapy comprising oral cyclosporine twice daily beginning on day -3 and continuing until day 35 followed by a taper until day 56. Patients also receive oral mycophenolate mofetil three times daily on days 0-40.

Patients with stable mixed chimerism on day 56 and no evidence of graft-vs-host disease may receive escalating doses of nonmobilized T-cell donor lymphocyte infusion (DLI) over 30 minutes. Patients may receive up to 4 DLIs if there is evidence of disease progression.

Patients are followed weekly for 3 months, monthly for 3 months, every 6 months for 2 years, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 3 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV renal cell carcinoma

  • Stable or progressive disease

• HLA genotypically identical related donor

  • No identical twins
• No brain metastasis

PATIENT CHARACTERISTICS:

Age:

• Under 75

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)*
• SGOT and SGPT no greater than 2 times ULN* NOTE: * Unless due to malignancy

Renal:

• Creatinine no greater than 2.0 mg/dL
• Calcium normal

Cardiovascular:

• Ejection fraction at least 50%

Pulmonary:

• DLCO at least 50% of predicted

Other:

• HIV-1 and HIV-2 negative
• HTLV-1 negative
• No ongoing active bacterial, viral, or fungal infection
• Not pregnant or nursing
• Fertile patients must use effective contraception during and for 12 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent growth factors during mycophenolate mofetil administration

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified