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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311545
Recruitment Status : Withdrawn (withdrawal of support for drug supply)
First Posted : April 6, 2006
Last Update Posted : February 20, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Monoclonal antibodies, such as CNTO 328, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well CNTO 328 works in treating patients with unresectable or metastatic kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Biological: CNTO 328 Phase 2

Detailed Description:



  • Assess the probability of response (confirmed complete and partial responses) in patients with unresectable or metastatic renal cell cancer treated with CNTO 328.


  • Assess the 6-month progression-free survival probability and median overall survival in these patients.
  • Evaluate the qualitative and quantitative toxicities of this treatment.
  • Investigate, in a preliminary manner, the association of tumor response with potential markers of anti-interleukin-6 activity.

OUTLINE: This is a multicenter study.

Patients receive CNTO 328 IV over 2 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete or partial response after 6 courses of therapy may receive an additional 6 courses.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer
Drug Information available for: Siltuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CNTO 328
CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks)
Biological: CNTO 328
Anti-IL-6 chimeric monoclonal antibody
Other Name: Siltuximab

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311545

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Jacek K. Pinski, MD University of Southern California
Study Chair: Philip C. Mack, Ph.D. UC Davis Cancer Center

Responsible Party: Southwest Oncology Group Identifier: NCT00311545     History of Changes
Other Study ID Numbers: CDR0000462096
S0351 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Southwest Oncology Group:
recurrent renal cell cancer
stage IV renal cell cancer
stage III renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents