Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: aldesleukin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|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, clear cell renal cell carcinoma