High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2

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 renal cell carcinoma (kidney cancer) cells. PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.

Detailed Description
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OBJECTIVES: Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2. Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug. Determine the toxicity of this drug in these patients. OUTLINE: This is a pilot study. Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1). Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity. Patients are followed every 6 months for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Official Title
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Treatment of Patients With Metastatic Renal Cell Carcinoma Who Have Failed Low Dose Intensity Interleukin-2 With High-Dose Intravenous Recombinant Interleukin-2

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 confirmed renal cell carcinoma Metastatic disease No pure papillary or sarcomatoid variants Measurable disease Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2 Documented disease progression No estimated hepatic replacement by tumor > 25% by CT scan or MRI No tumor involving the CNS or a major nerve PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 80-100% Life expectancy More than 3 months Hematopoietic Platelet count ≥ 80,000/mm^3 No sites of ongoing bleeding Hepatic See Disease Characteristics Bilirubin ≤ 1.4 mg/dL AST and ALT ≤ 3 times normal PT or PTT INR ≤ 1.2 Hepatitis B surface antigen negative Hepatitis C virus negative No coagulation disorders Renal Creatinine ≤ 1.6 mg/dL Cardiovascular No ongoing ischemia* No cardiac dysfunction* No abnormal ejection fraction* NOTE: *A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram Pulmonary FEV_1 ≤ 65% of predicted* Vital capacity ≤ 65% of predicted* NOTE: *Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph Other HIV negative No AIDS No systemic infections No other malignancy except carcinoma in situ No psychiatric illness that would preclude study participation or compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy Not specified Endocrine therapy No concurrent steroids Radiotherapy Not specified Surgery Not specified Other More than 28 days since other prior treatment for renal cell cancer No concurrent immunosuppressive agents

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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recurrent renal cell cancer, stage IV renal cell cancer