PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma. Determine the time to disease progression in patients treated with this drug. Determine the safety of this drug in these patients. Determine the quality of life of patients treated with this drug. Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients. OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy. PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.

Official Title
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Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: PEG-interferon alfa-2b


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed renal cell carcinoma Metastatic disease No prior therapy for advanced disease Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076 Bidimensionally measurable disease No brain metastases unless completely resected and without evidence of recurrence for at least six months PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 70-100% Life expectancy Not specified Hematopoietic WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases) Hepatitis B surface antigen negative Hepatitis C negative Renal Creatinine no greater than 2 mg/dL Cardiovascular No severe cardiac disease No New York Heart Association class III or IV cardiac disease No myocardial infarction within the past 12 months No ventricular tachyarrhythmias requiring ongoing treatment No unstable angina Pulmonary No severe asthma requiring chronic systemic steroids Other HIV negative Negative pregnancy test Fertile patients must use effective contraception No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization No prior or active autoimmune disease Medically controlled diabetes or thyroid dysfunction allowed No clinically significant acute viral or bacterial infection that requires specific therapy PRIOR CONCURRENT THERAPY: Biologic therapy No prior interleukin-2 No prior interferon alfa No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise No concurrent tumor vaccines No concurrent monoclonal antibodies No concurrent bone marrow/stem cell transplantation Chemotherapy No concurrent cytotoxic agents Endocrine therapy No concurrent high-dose systemic steroids Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed No concurrent hormonal therapy (including megestrol) Concurrent hormone replacement therapy or oral contraceptives allowed Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior major surgery Concurrent nephrectomy allowed Other At least 14 days since prior anti-infectious therapy No other concurrent investigational drugs

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PEG-interferon alfa-2b|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