Irradiated Donor Lymphocytes in Treating Patients With Metastatic Kidney Cancer

Immunotherapy for Patients With Renal Cell Carcinoma

RATIONALE: When irradiated donor lymphocytes are infused into the patient they may help the patient's immune system kill tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving irradiated donor lymphocytes works in treating patients with metastatic kidney cancer.

OBJECTIVES:

• Determine the response rate in patients with metastatic renal cell carcinoma treated with HLA-partially matched related donor lymphocytes.
• Determine the rate and kinetics of clinical/radiological response in patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Determine the rates of graft-vs-host disease in patients treated with this regimen.

OUTLINE: Patients receive irradiated donor lymphocytes IV over 1 hour on day 0. Treatment repeats every 8-16 weeks for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity.

Blood is collected periodically for research studies, including immunophenotypic analysis of cells and assay for cytotoxic T-lymphocytes and natural killer-cell activity against target cells.

After completion of study treatment, patients are followed for 60 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of clear cell renal cell carcinoma

  • Metastatic disease

• Measurable disease

• Previously treated with high-dose aldesleukin OR not eligible for or refused such therapy

• No brain metastases by MRI or CT scan

• HLA-partially matched (e.g., ≥ 2/6 HLA A, B, Dr match) related donor available

  • Patients who have no partially matched immediate family member available are eligible if they have a fully HLA-matched donor

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Bilirubin ≤ 2 times upper limit of normal
• Creatinine clearance ≥ 40 mL/min
• AST ≤ 3 times ULN
• Cardiac ejection fraction ≥ 45%
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics