interleukin-2 in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. purpose: phase iv trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.

objectives: * determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2. * determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen. * determine the incidence of adverse events in these patients. outline: this is a multicenter study. patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 2 years. projected accrual: a total of 464 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven metastatic renal cell carcinoma * clear cell * papillary * sarcomatoid * mixed * measurable or evaluable disease * evidence of disease following surgical resection of metastases * no cns disease patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * not specified hematopoietic: * hemoglobin at least 10 g/dl * wbc at least 4,000/mm3 * platelet count at least 100,000/mm3 hepatic: * not specified renal: * creatinine no greater than 1.8 mg/dl cardiovascular: * no new york heart association class iii or iv heart disease other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception (barrier plus 1 other method) * thyroid-stimulating hormone normal * no known hypersensitivity or allergy to components of recombinant human interleukin-2 * no known autoimmune disease (e.g., crohn's disease) * no other concurrent medical condition that would preclude study prior concurrent therapy: biologic therapy: * no prior recombinant human interleukin-2 * no concurrent interferon alfa chemotherapy: * no concurrent cytoxic chemotherapy endocrine therapy: * no concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy * no concurrent prophylactic glucocorticoids (replacement doses and topical use allowed) * no concurrent systemic corticosteroids radiotherapy: * at least 4 weeks since prior radiotherapy * no prior radiotherapy to index lesion * no concurrent radiotherapy surgery: * see disease characteristics * prior surgery for renal cell carcinoma allowed other: * no prior systemic therapy for renal cell carcinoma * at least 4 weeks since prior investigational drugs * no other concurrent investigational drugs or participation in another clinical study * no concurrent iodinated radiocontrast dye * no concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)

Keywords: stage iv renal cell cancer recurrent renal cell cancer clear cell renal cell carcinoma