interleukin-2 and interferon in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: biological therapies, such as interleukin-2 and interferon, may stimulate the immune system in different ways and stop tumor cells from growing. it is not yet known whether interleukin-2 given by infusion is more effective than interleukin-2 given by injection when combined with interferon in treating metastatic kidney cancer. purpose: this randomized phase iii trial is studying interleukin-2 given by infusion to see how well it works compared to interleukin-2 given by injection when combined with interferon in treating patients with metastatic kidney cancer.

objectives: primary * compare the overall survival of patients with metastatic renal cell cancer treated with intravenous vs subcutaneous interleukin-2 in combination with interferon alfa. secondary * compare progression-free survival of patients treated with these regimens. * compare response rates (complete and partial) in patients treated with these regimens. * compare the toxicity of these regimens in these patients. * compare quality of life of patients treated with these regimens. outline: this is an open-label, randomized, parallel-group, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients receive induction therapy comprising interleukin-2 (il-2) iv continuously over days 1-5, 15-19, 43-47, and 57-61 (weeks 1, 3, 7, and 9) and interferon alfa (ifn-α) subcutaneously (sc) three times weekly in weeks 1-3 and 7-9. patients then undergo restaging. patients achieving a complete response (cr), partial response (pr), or stable disease (sd) then receive maintenance therapy comprising il-2 iv continuously over 5 days and ifn-α sc three times weekly in weeks 1, 5, 9, and 13. * arm ii: patients receive induction therapy comprising il-2 sc twice daily on days 1-5, 8-12, 15-19, and 22-26 (weeks 1-4). patients also receive ifn-α sc three times weekly in weeks 1-4 and 6-9. patients then undergo restaging. patients achieving a cr, pr, or sd then receive maintenance therapy comprising il-2 sc as in induction therapy and ifn-α sc three times weekly in weeks 1-4 and 8-11. quality of life is assessed at baseline, at the end of induction therapy, and then at the end of maintenance therapy. after completion of treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 220 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic renal cell adenocarcinoma * more than one resectable metastatic site * no unresectable lesions after local curative treatment (i.e., radiotherapy) * in case of secondary lesions suspected on imaging (\< 1 cm and/or sparse lesions), metastatic disease must be confirmed by biopsy or disease progression documented by imaging performed over several weeks * if patient has known prior metastatic lesions, progressive disease must have been confirmed within the past 3 months by noninvasive techniques * nephrectomized * measurable or evaluable disease * no brain metastases patient characteristics: * karnofsky performance status 90-100% * hematocrit ≥ 30% * wbc ≥ 4,000/mm\^3 * platelet count ≥ 120,000/mm\^3 * bilirubin normal * creatinine ≤ 1.7 mg/dl * fev_1 ≥ 50% * no severe cardiac dysfunction (i.e., grade iii/iv heart disease), including any of the following: * congestive heart failure * coronary artery disease * uncontrolled hypertension * severe arrhythmia * no active infections requiring antibiotic treatment * no severe neuropsychiatric condition * no geographical, psychological, or familial conditions that would preclude study treatment * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * lvef ≥ 50% * no severe autoimmune disease * no known chronic hepatitis * no hiv positivity * no hepatitis b surface antigen positivity * no prior or concurrent other cancer, except basal cell skin cancer or carcinoma in situ of the cervix * no severe pulmonary, hepatic, or renal condition that would preclude study treatment prior concurrent therapy: * see disease characteristics * at least 6 weeks since prior wide-field radiotherapy * no prior allograft * no prior cytokines or chemotherapy * no concurrent corticosteroids

Keywords: stage iv renal cell cancer recurrent renal cell cancer