Kidney Cancer Clinical Trial
Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer
Summary
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.
Full Description
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.
Eligibility Criteria
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
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There is 1 Location for this study
Cleveland Ohio, 44195, United States
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