Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

CNTO 328 in Treating Patients With Unresectable or Metastatic Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI SWOG-S0351 S0351, NCT00311545

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

• Zubrod performance status 0-2
• Absolute granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Primo Lara, MD, Protocol chair		Ph: 916-734-3771
Ulka Vaishampayan, MD, Protocol co-chair		Ph: 313-576-8715; 800-527-6266 Email: vaishamu@karmanos.org

Registry Information
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
Registered in ClinicalTrials.gov		NCT00311545
Date Submitted to PDQ		2005-12-01
Information Last Verified		2006-04-13
NCI Grant/Contract Number		CA32102