Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Interleukin-2 In An Alternative Dose (The Iliad Trial): Treatment Of Patients With Metastatic Renal Cell Carcinoma With Low Dose Proleukin

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.

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)