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

NCT00311545 | Withdrawn Phase 2 DMC

• 3 other identifiers: CDR0000462096S0351U10CA032102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer; stage III renal cell cancer

Study Arms (1)

CNTO 328

EXPERIMENTAL

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

Biological: CNTO 328

Interventions

CNTO 328 BIOLOGICAL

Anti-IL-6 chimeric monoclonal antibody

Also known as: Siltuximab

CNTO 328

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

siltuximab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jacek K. Pinski, MD

  University of Southern California

  STUDY CHAIR

• Philip C. Mack, Ph.D.

  UC Davis Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 6, 2006
• Last Updated: February 20, 2013

Record last verified: 2013-02