lymphocyte therapy in treating patients with kidney cancer

Conditions: Kidney Cancer

Summary: 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.

objectives: * 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.

Eligibility criteria:
disease characteristics: * 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 patient characteristics: age: * over 16 performance status: * ecog 0-2 hematopoietic: * 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 hepatic: * pt no greater than 1.5 times control * ptt less than 1.5 times control * hepatitis b surface antigen negative renal: * creatinine no greater than 4.0 mg/dl * calcium no greater than 12 mg/dl * no symptomatic hypercalcemia cardiovascular: * no uncontrolled or severe cardiac disease, e.g.: * no myocardial infarction within 6 months * no congestive heart failure other: * 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 disorders * 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 biologic therapy: * no concurrent immunotherapy chemotherapy: * no concurrent chemotherapy endocrine therapy: * 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) * androgens * progestins * antiestrogens * antiandrogens * lhrh analogues or antagonists * other hormones radiotherapy: * not specified surgery: * see disease characteristics * no prior solid organ allograft * more than 3 weeks since major surgery, including nephrectomy

Keywords: stage iii renal cell cancer stage iv renal cell cancer recurrent renal cell cancer