S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed metastatic or unresectable primary renal cell carcinoma

• Measurable disease

  • Soft tissue disease within a prior radiation field may be considered measurable disease provided all of the following are true:

    • Patient also has measurable disease outside of the irradiated field
    • Disease within the irradiated field has progressed since prior radiotherapy
    • Radiotherapy was completed more than 2 months ago
• Ineligible for high-dose interleukin-2

• No treated or untreated brain metastases

  • No history of brain metastases
  • Patients with clinical evidence of brain metastases must have brain CT scan or MRI negative for metastatic disease within 56 days prior to study entry

PATIENT CHARACTERISTICS:

• Zubrod performance status 0-2
• Absolute granulocyte count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine clearance ≥ 40 mL/min
• Bilirubin ≤ 3 times upper limit of normal (ULN)
• SGOT ≤ 3 times ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception

• No more than 2 of the following:

  • Zubrod PS 2
  • Lactate dehydrogenase > 1.5 times ULN
  • Hemoglobin \< lower limit of normal
  • Calcium > 10 mg/dL
  • Absence of prior nephrectomy

• No uncontrolled intercurrent illness, including any of the following:

  • Uncontrolled diabetes mellitus
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Psychiatric illness or social situation that would limit compliance with study requirements
• No HIV positivity

• No other prior malignancy, excluding the following:

  • Adequately treated basal cell or squamous cell skin cancer
  • In situ cervical cancer
  • Adequately treated stage I or II cancer for which the patient is currently in complete remission
  • Any other cancer for which the patient has been disease free for 5 years

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 28 days since prior tumor resection and recovered
• No prior immunotherapy or chemotherapy regimens with interferon (IFN) and/or interleukin-2 (IL-2) or the combination of IFN/IL-2
• No prior cytotoxic chemotherapy for renal cell cancer
• No prior murine or chimeric proteins or human/murine recombination products (i.e., other chimeric monoclonal antibodies)
• No concurrent radiotherapy or systemic therapy for renal cell cancer