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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cytokines in the Treatment of Metastatic Renal Cell Carcinoma (MRCC): Intravenous Interleukin and Subcutaneous Interferon-α Versus Subcutaneous Interleukin and Interferon-α for Good Prognosis Patients [PERCY DUO]

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant interferon alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: recombinant interferon alfa|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer