Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Case Comprehensive Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Kidney Cancer

Interventions

aldesleukinBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Northwestern Connecticut Oncology-Hematology Associates

Torrington, Connecticut, United States

Ireland Cancer Center

Cleveland, Ohio, United States

Data from ClinicalTrials.gov

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