RATIONALE: Treating a person's lymphocytes with interleukin-2 and monoclonal antibody may
help them kill more cancer cells when they are put back in the body.
PURPOSE: This phase II trial is studying how well lymphocyte therapy works in treating
patients with stage III or stage IV kidney cancer.
- Evaluate the ability of autologous lymphocyte therapy (ALT) given as adjuvant therapy
following nephrectomy and/or complete surgical resection of any metastatic disease to
delay or prevent metastatic recurrence in patients with high-risk renal cell carcinoma.
- Determine the incidence of tumor recurrence and the survival of these patients treated
with this regimen.
- Determine the toxicity/morbidity of this regimen in these patients.
- Explore the relationship between clinical response and in vitro autologous lymphocyte
characteristics, including lytic activity, cytokine production, response to cytokines,
and phenotypic profile in these patients treated with this regimen.
- Assess patient immune status before, during, and after therapy.
OUTLINE: Patients are stratified according to postnephrectomy interval (less than 3 months
vs more than 3 months), extent of lymph node involvement (N1 vs N2-N3), interleukin-1
concentration in initial autologous lymphocyte culture (less than 500 pg/mL vs greater than
500 pg/mL), and prenephrectomy treatment.
Mononuclear cells are collected by apheresis on day 1 and cultured with interleukin-2 and
monoclonal antibody OKT3. After cellular production, the autologous lymphocytes are
reinfused over at least 30 minutes. Treatment repeats monthly for 6 months and then every 3
months for 6 months in the absence of unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then
annually for 5 years.
PROJECTED ACCRUAL: A total of 10-90 patients will accrued for this study within 3 years.
- Histologically documented and completely resected stage III or stage IV renal cell
carcinoma, clinically staged within 2 months prior to initiation of therapy
- No evidence of nephrotic syndrome
- Over 16
- ECOG 0-2
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count 50,000/mm3 to 500,000/mm^3
- Hemoglobin at least 10 g/dL
- No hematologic abnormalities
- PT no greater than 1.5 times control
- PTT less than 1.5 times control
- Hepatitis B surface antigen negative
- Creatinine no greater than 4.0 mg/dL
- Calcium no greater than 12 mg/dL
- No symptomatic hypercalcemia
- No uncontrolled or severe cardiac disease, e.g.:
- No myocardial infarction within 6 months
- No congestive heart failure
- HIV negative
- No significant organ dysfunction
- No other serious medical illness that would limit life expectancy
- No significant CNS disease including uncontrolled or untreated psychiatric or seizure
- No uncontrolled bacterial, viral, or fungal infection
- No active peptic or duodenal ulcer
- Adequate peripheral venous access required
- No prior malignancy within past 5 years except inactive nonmelanoma skin cancer or
carcinoma in situ of the cervix
- Not pregnant
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- No other concurrent postnephrectomy adjuvant therapy
- No concurrent immunotherapy
- No concurrent chemotherapy
- More than 1 week since prior corticosteroids (except as inhalation therapy for
respiratory ailments or replacement for adrenal insufficiency)
- No concurrent therapy with the following:
- Estrogens (except as postmenopausal replacement therapy)
- LHRH analogues or antagonists
- Other hormones
- Not specified
- See Disease Characteristics
- No prior solid organ allograft
- More than 3 weeks since major surgery, including nephrectomy