• Graft vs tumor effect by CAT scan at days 30, 60, and 100 following transplant [ Designated as safety issue: No ]
  

• Disease-free survival by CAT scan at 6 months and 1 year [ Designated as safety issue: No ]
  

OBJECTIVES:

• Determine the antitumor effect of allogeneic peripheral blood stem cell transplantation (PBSCT) in patients with metastatic renal cell carcinoma.
• Evaluate the safety and toxicity of a nonmyeloablative, low-intensity, preparative regimen followed by an HLA-matched allogeneic PBSCT in these patients.
• Determine engraftment by measuring donor-recipient chimerism in lymphoid and myeloid lineages in patients treated with this regimen.
• Determine the relationship between donor-host chimerism and the incidence of acute and chronic graft-versus-host disease in patients treated with this regimen.
• Determine the effect of lymphocyte infusions on donor-host chimerism in this patient population.
• Determine the response rate, disease-free survival, overall survival, and mortality from the procedure or tumor progression in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of a conditioning regimen. (Dose escalation completed as of 10/1/03.)

Patients receive 1 of 3 dose levels of conditioning chemotherapy prior to peripheral blood progenitor cell (PBPC) transplantation. (Dose levels 2 and 3 are closed to accrual as of 10/1/03.)

• Dose level 1: Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes daily on days -5 to -1.
• Dose level 2 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour on days -7 and -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.
• Dose level 3 (closed to accrual as of 10/1/03): Patients receive cyclophosphamide IV over 1 hour daily on days -8 to -6, fludarabine IV over 30 minutes daily on days -5 to -1, and antithymocyte globulin daily on days -5 to -2.

Patients undergo mobilized CD34+ PBPC transplantation on day 0. PBPC transplantation may be repeated on days 1 and 2 if deemed necessary.

Patients with progressive disease on days 15-30, day 60, or day 100, without graft-versus-host disease, receive infusion(s) of donor lymphocytes. Further donor lymphocyte infusions after day 100 may be given at the discretion of the attending physician.

Patients are followed every 2 months for 6 months, every 3 months for 2 years, and then every 6 months for 2.5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically proven metastatic renal cell carcinoma not amenable to complete surgical resection and progressive despite immunotherapy
• Bidimensionally evaluable clinically or radiographically
• HLA 6/6 or 5/6 matched family donor available
• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 80

Performance status:

• ECOG 0 or 1

Life expectancy:

• At least 3 months

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 4 mg/dL
• Transaminases no greater than 3 times upper limit of normal

Renal:

• Creatinine no greater than 2.5 mg/dL
• No malignancy-associated hypercalcemia (< 2.5 mmol/L)

Cardiovascular:

• Left ventricular ejection fraction greater than 40%

Pulmonary:

• DLCO greater than 65% of predicted

Other:

• Not pregnant
• HIV negative
• No major organ dysfunction that would preclude transplantation
• No other malignancies except basal cell or squamous cell skin cancer
• No psychiatric disorder or mental deficiency that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 1 month since prior treatment for renal cell carcinoma