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Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilex
ClinicalTrials.gov Identifier:
NCT00087022
First received: July 8, 2004
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether monoclonal antibody therapy is effective in treating kidney cancer.

PURPOSE: This randomized phase III trial is studying monoclonal antibody therapy to see how well it works in treating patients who have undergone surgery for nonmetastatic primary kidney cancer.


Condition Intervention Phase
Kidney Cancer
 Biological: girentuximab
Other: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind Phase III Study To Evaluate Adjuvant cG250 Treatment Versus Placebo In Patients With Clear Cell RCC And High Risk of Recurrence (ARISER)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wilex:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: Local 360 DFS events ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life by EORTC Quality of Life Questionnaire-C30 at 3, 6, and 12 months [ Time Frame: At final analysis ] [ Designated as safety issue: No ]
  • Safety by NCI CTCAE v3.0 at 1 month following study treatment [ Time Frame: At final analysis ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of WX-G250 [ Time Frame: At final analysis ] [ Designated as safety issue: No ]

Enrollment: 864
Study Start Date: July 2004
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes once weekly for 24 weeks.
 Biological: girentuximab
Given IV
Placebo Comparator: Arm II
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
 Other: placebo
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the disease-free and overall survival of patients with primary clear cell renal cell carcinoma at high risk for recurrence treated with chimeric monoclonal antibody cG250 (WX-G250) vs placebo in an adjuvant setting.

Secondary

  • Evaluate the safety of these drugs in these patients.
  • Assess the quality of life of patients treated with this drug.
  • Perform pharmacokinetic analysis of WX-G250.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to risk criteria and participating centers (US vs Non-US). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive monoclonal chimeric antibody cG250 (WX-G250) IV over 15 minutes once weekly for 24 weeks.
  • Arm II: Patients receive placebo IV over 15 minutes once weekly for 24 weeks. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Blood samples are collected for pharmacokinetic analysis.

Quality of life is assessed at baseline, at weeks 12 and 24 during treatment, and then at 6 months after completion of study treatment.

Patients are followed every 3 months during years 1 and 2, every 6 months during years 3 and 4, and then annually during year 5 and thereafter.

PROJECTED ACCRUAL: A total of 864 patients out of the expected 856 (428 per treatment arm) were accrued for this trial.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary clear cell renal cell carcinoma

    • Meets 1 of the following high risk criteria:

      • T3a, N0/NX, M0 OR T3b, N0/NX, M0 OR T3c, N0/NX, M0 OR T4, N0/NX, M0
      • Any T stage and N + disease and M0
      • T1b, N0/NX, M0 OR T2, N0/NX, M0, each with grade ≥ 3 (Fuhrman or any other nuclear grading system with at least 3 grades)

  • Prior nephrectomy (total or partial) of primary renal cell carcinoma with documented clear cell histology within the past 12 weeks

    • No evidence of macroscopic or microscopic residual disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Platelet count > 100,000/mm^3
  • WBC > 3,000/mm^3
  • Hemoglobin > 10 g/dL

Hepatic

  • AST and ALT < 3 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Hepatitis B surface antigen (HbsAg) negative
  • Hepatitis C antibody negative

Renal

  • Creatinine < 2.0 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV I and II negative
  • No concurrent unrelated illness which can significantly jeopardize patients' clinical status
  • No active infection
  • No inflammation
  • No medical condition or laboratory abnormalities that would preclude study participation
  • No other malignancies within the past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 5 years since prior immunotherapy
  • No prior murine or chimeric antibody therapy

Chemotherapy

  • More than 5 years since prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids above Cushing dose for another disease

    • Physiologic corticosteroid replacement therapy allowed at discretion of the primary investigator

Radiotherapy

  • More than 5 years since prior radiotherapy

Surgery

  • See Disease Characteristics
  • No prior organ transplantation

Other

  • No concurrent immunosuppressive agents (e.g., cyclosporine or tacrolimus)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087022

  Show 56 Study Locations
Sponsors and Collaborators
Wilex
Investigators
Study Director: Pia Kloepfer, MD Wilex
Principal Investigator: Arie Belldegrun, MD, FACS Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT00087022     History of Changes
Obsolete Identifiers: NCT00209183
Other Study ID Numbers: WX-2003-07-HR, WILEX-WX-2003-07-HR, ARISER, UCLA-0404015-01, CDR0000372830, NCI-2012-00491
Study First Received: July 8, 2004
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wilex:
clear cell renal cell carcinoma
stage I renal cell cancer
stage II renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013