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

Primary Purpose

Kidney Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CNTO 328
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Experimental

    Arm Label

    CNTO 328

    Arm Description

    CNTO 328, anti-IL-6 monoclonal antibody; 6 mg/kg, IV, q 2wks x 12 cycles (1 cycle = 2 wks)

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2006
    Last Updated
    February 19, 2013
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00311545
    Brief Title
    S0351, CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    withdrawal of support for drug supply
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    OBJECTIVES: Primary Assess the probability of response (confirmed complete and partial responses) in patients with unresectable or metastatic renal cell cancer treated with CNTO 328. Secondary 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Cancer
    Keywords
    recurrent renal cell cancer, stage IV renal cell cancer, stage III renal cell cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacek K. Pinski, MD
    Organizational Affiliation
    University of Southern California
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Philip C. Mack, Ph.D.
    Organizational Affiliation
    UC Davis Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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