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

Sponsor

Southwest Oncology Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00311545

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Cancer	Biological: CNTO 328	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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

Arms and Interventions

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 Names: Siltuximab

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 Names:

Siltuximab

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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