Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00045279


Primary Contact:

Study Chair
Robert J. Motzer, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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