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

Last updated: October 31, 2018
Sponsor: Wilex
Overall Status: Completed

Phase

3

Condition

Urothelial Tract Cancer

Kidney Cancer

Renal Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT00087022
WX-2003-07-HR
WILEX-WX-2003-07-HR
ARISER
NCI-2012-00491
CDR0000372830
UCLA-0404015-01
  • Ages 18-120
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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)

Study Design

Total Participants: 864
Study Start date:
July 01, 2004
Estimated Completion Date:
October 31, 2012

Study 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.

Connect with a study center

  • Instituto Alexander Fleming

    Cramer, Buenos Aires 1426
    Argentina

    Site Not Available

  • Hospital Zonal General de Agudos

    Ranelagh, Buenos Aires 1886
    Argentina

    Site Not Available

  • Complejo Medico de la Policia Federal Argentina

    Buenos Aires, Capital Federal 1424
    Argentina

    Site Not Available

  • Unidad Oncologica Del Neuquen

    Neuquen,
    Argentina

    Site Not Available

  • Centro de Oncologia Rosario

    Rosario, 2000
    Argentina

    Site Not Available

  • Clinical Especializada ISIS

    Santa Fe, S300FFV
    Argentina

    Site Not Available

  • Biocancer Centro de Pesq e Trat de Cancer SA

    Belo-Horizonte, Minas Gerais 30240-060
    Brazil

    Site Not Available

  • Nucleo de Oncologia da Bahia

    Bahia, 40170-070
    Brazil

    Site Not Available

  • Instituto Nacional de Cancer

    Rio de Janeiro, 20230-130
    Brazil

    Site Not Available

  • Hospital Sirio-Libanes

    Sao Paulo, 01308-050
    Brazil

    Site Not Available

  • Universidade Federal de Sao Paulo

    Sao Paulo, 04023-900
    Brazil

    Site Not Available

  • G. Steinhoff Clinical Research

    Victoria, British Columbia V8V 3N1
    Canada

    Site Not Available

  • McMaster Institute of Urology at St. Joseph Healthcare

    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • CMX Research, Incorporated

    Oakville, Ontario L6J 3J3
    Canada

    Site Not Available

  • Male Health Centre - Oakville

    Oakville, Ontario L6H 3PI
    Canada

    Site Not Available

  • Male Health Centre - North York

    Toronto, Ontario M6A 3B5
    Canada

    Site Not Available

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Anchorage, Alaska 99508
    United States

    Site Not Available

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California 90095-1781
    United States

    Site Not Available

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Helen F. Graham Cancer Center at Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Atlantic Urological Associates - Daytona Beach

    Daytona Beach, Florida 32114
    United States

    Site Not Available

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Southeastern Research Group

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Augusta Oncology Associates - Walton Way

    Augusta, Georgia 30901
    United States

    Site Not Available

  • North Idaho Urology - Coeur d'Alene

    Coeur d'Alene, Idaho 83814-2668
    United States

    Site Not Available

  • Northeast Indiana Urology, PC

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa 52242-1002
    United States

    Site Not Available

  • Hematology and Oncology Specialists, LLC - Metairie

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences

    Shreveport, Louisiana 71130-3932
    United States

    Site Not Available

  • Regional Urology, LLC

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Werner-Francis Urology Associates, LLC

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Lahey Clinic Medical Center - Burlington

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Nevada Cancer Institute

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Community Care Physicians, PC at Urological Institute of NENY

    Albany, New York 12209
    United States

    Site Not Available

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    Bronx, New York 10466
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263-0001
    United States

    Site Not Available

  • AccuMed Research Associates

    Garden City, New York 11530
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • Hudson Valley Urology, PC

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Alliance Urology Specialists - Greensboro

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Carolina BioOncology Institute

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio 43214-3998
    United States

    Site Not Available

  • Urological Associates of Lancaster, Limited

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • Urology Associates

    Nashville, Tennessee 37209
    United States

    Site Not Available

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232-6838
    United States

    Site Not Available

  • Mary Crowley Medical Research Center at Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Urology Associates of South Texas, PA

    McAllen, Texas 78503
    United States

    Site Not Available

  • Urology San Antonio, PA - Fredericksburg

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont 05405-0110
    United States

    Site Not Available

  • CCOP - Virginia Mason Research Center

    Seattle, Washington 98101
    United States

    Site Not Available

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