• 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 ]

• Disease response
• Safety as measured by transplant related mortality on day 200 after allografting
• Donor engraftment on day 56 after allografting

RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy and radiation therapy together with peripheral stem cell transplant and donor white blood cells and to see how well it works in treating patients with metastatic kidney cancer.

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.

• Biological: graft-versus-tumor induction therapy
• Biological: therapeutic allogeneic lymphocytes
• Drug: cyclosporine
• Drug: fludarabine phosphate
• Drug: mycophenolate mofetil
• Procedure: peripheral blood stem cell transplantation
• Radiation: radiation therapy

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