Interleukin-2 and Interferon in Treating Patients With Metastatic Kidney Cancer

Centre Leon Berard220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Conditions

Kidney Cancer

Interventions

aldesleukinBIOLOGICAL

recombinant interferon alfaBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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