Kidney Cancer Clinical Trial
Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
Summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.
PURPOSE: Phase IV trial to study the effectiveness of interleukin-2 in treating patients who have metastatic kidney cancer.
Full Description
OBJECTIVES:
Determine the overall response rate, complete and partial response rates, and duration of response in patients with metastatic renal cell carcinoma treated with low-dose interleukin-2.
Determine the overall survival, one-year progression-free survival, and two-year progression-free survival in patients treated with this regimen.
Determine the incidence of adverse events in these patients.
OUTLINE: This is a multicenter study.
Patients receive low-dose interleukin-2 subcutaneously 5 days a week for 6 weeks. Courses repeat every 9 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 464 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven metastatic renal cell carcinoma
Clear cell
Papillary
Sarcomatoid
Mixed
Measurable or evaluable disease
Evidence of disease following surgical resection of metastases
No CNS disease
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
Karnofsky 60-100%
Life expectancy:
Not specified
Hematopoietic:
Hemoglobin at least 10 g/dL
WBC at least 4,000/mm3
Platelet count at least 100,000/mm3
Hepatic:
Not specified
Renal:
Creatinine no greater than 1.8 mg/dL
Cardiovascular:
No New York Heart Association class III or IV heart disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception (barrier plus 1 other method)
Thyroid-stimulating hormone normal
No known hypersensitivity or allergy to components of recombinant human interleukin-2
No known autoimmune disease (e.g., Crohn's disease)
No other concurrent medical condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior recombinant human interleukin-2
No concurrent interferon alfa
Chemotherapy:
No concurrent cytoxic chemotherapy
Endocrine therapy:
No concurrent hormonal therapy (e.g., medroxyprogesterone) other than estrogen replacement therapy
No concurrent prophylactic glucocorticoids (replacement doses and topical use allowed)
No concurrent systemic corticosteroids
Radiotherapy:
At least 4 weeks since prior radiotherapy
No prior radiotherapy to index lesion
No concurrent radiotherapy
Surgery:
See Disease Characteristics
Prior surgery for renal cell carcinoma allowed
Other:
No prior systemic therapy for renal cell carcinoma
At least 4 weeks since prior investigational drugs
No other concurrent investigational drugs or participation in another clinical study
No concurrent iodinated radiocontrast dye
No concurrent drugs for another indication that has purported activity in treatment of neoplasia (e.g., thalidomide)
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There are 2 Locations for this study
Torrington Connecticut, 06790, United States
Cleveland Ohio, 44106, United States
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