Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients with metastatic kidney cancer.

Detailed Description
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OBJECTIVES: Primary Determine the objective response rate in patients with metastatic renal clear cell carcinoma treated with interferon alfa-1b. Secondary Determine the toxicity of this drug in these patients. OUTLINE: This is an open-label study. Patients receive interferon alfa-1b subcutaneously daily. Treatment continues in the absence of unacceptable toxicity or disease progression. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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A Phase II Trial of Interferon Alpha-1b (IFN Alpha-1b) in Patients With Metastatic Clear Cell Renal Carcinoma

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: recombinant interferon alpha-1b


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed predominantly renal clear cell carcinoma Clinical evidence of OR biopsy-proven metastatic disease to a site or sites distant from the primary tumor Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan Good- or intermediate-risk category as defined by having ≤ 2 of the following factors: Time from initial diagnosis to treatment < 1 year Karnofsky performance status < 80% Hemoglobin < lower limit of normal Corrected calcium > 10.0 mg/dL Lactate dehydrogenase (LDH) > 1.5 times upper limit of normal (ULN) No major clinical ascites or pleural effusion No CNS metastases by neurologic exam and CT scan or MRI PATIENT CHARACTERISTICS: ECOG performance status 0-1 Life expectancy ≥ 3 months WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 9.5 g/dL Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients) Calcium normal Total bilirubin ≤ 1.5 mg/dL AST ≤ 3.0 times normal Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception prior to and for the duration of study treatment No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV) No known positivity for HIV or hepatitis B surface antigen No history of seizure disorders No local and/or systemic infections requiring antibiotics within 28 days prior to study entry No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for > 3 years PRIOR CONCURRENT THERAPY: No prior organ allografts No prior interferon No prior cytokine-based therapy for metastatic disease Prior radiotherapy is allowed for the control of pain from skeletal lesions provided treatment was completed > 28 days prior to study entry and patient has recovered No major surgery requiring general anesthesia within 28 days prior to study entry No more than 2 prior therapies for metastatic disease No concurrent palliative radiotherapy No concurrent chemotherapy No concurrent hormonal therapy except for hormones administered for nondisease-related conditions (e.g., insulin for diabetes) No concurrent steroid use except ongoing replacement therapy with physiologic doses of corticosteroids No concurrent dexamethasone or other steroidal anti-emetics or anti-inflammatories No other concurrent anticancer therapy No concurrent aspirin or barbiturates No other concurrent investigational 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant interferon alpha-1b|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 
| Efficacy |  |  | 

 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