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

NCT ID: NCT00311545

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CNTO 328

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

Group Type: EXPERIMENTAL

CNTO 328

Intervention Type: BIOLOGICAL

Anti-IL-6 chimeric monoclonal antibody

Interventions

CNTO 328

Anti-IL-6 chimeric monoclonal antibody

Intervention Type: BIOLOGICAL

Other Intervention Names

Siltuximab

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacek K. Pinski, MD

Role: STUDY_CHAIR

University of Southern California

Philip C. Mack, Ph.D.

Role: STUDY_CHAIR

UC Davis Cancer Center

Other Identifiers

S0351

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000462096

Identifier Type: -

Identifier Source: org_study_id