high-dose intravenous interleukin-2 in treating patients with metastatic renal cell carcinoma (kidney cancer) that has not responded to previous low-dose intravenous or subcutaneous interleukin-2

Conditions: Kidney Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill renal cell carcinoma (kidney cancer) cells. purpose: this phase ii trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

objectives: * determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (il-2) when treated with high-dose intravenous il-2. * determine the overall survival, disease-free survival, and time to progression in patients treated with this drug. * determine the toxicity of this drug in these patients. outline: this is a pilot study. patients receive high-dose interleukin-2 iv every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1). patients are assesed for response 2 months after initiation of treatment. patients with responding or stable disease receive a second course of therapy. patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity. patients are followed every 6 months for survival. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed renal cell carcinoma * metastatic disease * no pure papillary or sarcomatoid variants * measurable disease * failed prior subcutaneous or intravenous (dose ≤ 50,000 iu/kg/day) interleukin-2 * documented disease progression * no estimated hepatic replacement by tumor \> 25% by ct scan or mri * no tumor involving the cns or a major nerve patient characteristics: age * 18 and over performance status * karnofsky 80-100% life expectancy * more than 3 months hematopoietic * platelet count ≥ 80,000/mm\^3 * no sites of ongoing bleeding hepatic * see disease characteristics * bilirubin ≤ 1.4 mg/dl * ast and alt ≤ 3 times normal * pt or ptt inr ≤ 1.2 * hepatitis b surface antigen negative * hepatitis c virus negative * no coagulation disorders renal * creatinine ≤ 1.6 mg/dl cardiovascular * no ongoing ischemia\* * no cardiac dysfunction\* * no abnormal ejection fraction\* note: \*a cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram pulmonary * fev_1 ≤ 65% of predicted\* * vital capacity ≤ 65% of predicted\* note: \*pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph other * hiv negative * no aids * no systemic infections * no other malignancy except carcinoma in situ * no psychiatric illness that would preclude study participation or compliance * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * see disease characteristics chemotherapy * not specified endocrine therapy * no concurrent steroids radiotherapy * not specified surgery * not specified other * more than 28 days since other prior treatment for renal cell cancer * no concurrent immunosuppressive agents

Keywords: recurrent renal cell cancer stage iv renal cell cancer