S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
Kidney Cancer
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Experimental
CNTO 328
CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks)