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A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), In Patients With Advanced or Metastatic Renal Cell Cancer



- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jacek K. Pinski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Kidney Cancer
  • recurrent renal cell cancer
  • stage IV renal cell cancer
  • stage III renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms