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

Study Overview
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Brief Summary
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RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. Assess the toxicity of this regimen. OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 14 patients will be entered.

Official Title
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TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: aldesleukin
* Biological: recombinant interferon alfa
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven renal cell cancer that is metastatic No greater than 50% estimated hepatic replacement by tumor on CT or MRI No symptomatic involvement of the CNS or a major nerve Measurable disease required Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50%-100% Life expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: AST and ALT no greater than 5 times normal Renal: Creatinine less than 4.0 mg/dL Cardiovascular: No symptomatic angina No untreated coronary artery disease No refractory arrhythmia No abnormal left ventricular function Pulmonary: No dyspnea on minimal exertion Other: No site of ongoing bleeding No systemic infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that precludes informed consent or protocol treatment No second malignancy except: Basal cell skin carcinoma Carcinoma in situ of the cervix Not pregnant or nursing Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 28 days since prior treatment for renal cell cancer

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|
|Biological: recombinant interferon alfa|nan|
|Procedure: conventional surgery|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