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

Phase 3

Completed

Conditions: Kidney Cancer

Interventions: Biological: girentuximab
Other: placebo

Registration Number: NCT00087022

Lead Sponsor: Heidelberg Pharma AG

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 864

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	girentuximab	Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
Arm II	placebo	Patients receive placebo IV over 15 minutes once weekly for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)	Disease Free Survival (DFS) calculated from the date of randomization up to and including the date of documented relapse as confirmed by the CT, death or start of new anti-tumor therapy.
Overall Survival	After 419 OS events or 60 months after the last patient has been enrolled, whichever is the later (median follow-up of 4.5 years)	Overall Survival (OS) calculated from the date of randomization to the date of death. Patients with no documented death will be censored at the date of their last study evaluation.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of WX-G250	Week 8	Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
Quality of Life - Global Health Status	At 12 months	Quality of life by EORTC Quality of Life Questionnaire-C30 - Global Health Status at 12 months. A high score for the global health status/QoL represents a high QoL with 0 being the minimum and 100 being the maximum.

Trial Locations

Locations (55): Southeastern Research Group
🇺🇸
Tallahassee, Florida, United States
Northeast Indiana Urology, PC
🇺🇸
Fort Wayne, Indiana, United States
Vermont Cancer Center at University of Vermont
🇺🇸
Burlington, Vermont, United States
Nevada Cancer Institute
🇺🇸
Las Vegas, Nevada, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
Helen F. Graham Cancer Center at Christiana Hospital
🇺🇸
Newark, Delaware, United States
Atlantic Urological Associates - Daytona Beach
🇺🇸
Daytona Beach, Florida, United States
Mayo Clinic - Jacksonville
🇺🇸
Jacksonville, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸
Atlanta, Georgia, United States
Augusta Oncology Associates - Walton Way
🇺🇸
Augusta, Georgia, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸
Iowa City, Iowa, United States
Hematology and Oncology Specialists, LLC - Metairie
🇺🇸
Metairie, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
🇺🇸
Shreveport, Louisiana, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Werner-Francis Urology Associates, LLC
🇺🇸
Greenbelt, Maryland, United States
Lahey Clinic Medical Center - Burlington
🇺🇸
Burlington, Massachusetts, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸
Saint Louis, Missouri, United States
Community Care Physicians, PC at Urological Institute of NENY
🇺🇸
Albany, New York, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
AccuMed Research Associates
🇺🇸
Garden City, New York, United States
Mount Sinai School of Medicine
🇺🇸
New York, New York, United States
Hudson Valley Urology, PC
🇺🇸
Poughkeepsie, New York, United States
Alliance Urology Specialists - Greensboro
🇺🇸
Greensboro, North Carolina, United States
Carolina BioOncology Institute
🇺🇸
Huntersville, North Carolina, United States
Riverside Methodist Hospital Cancer Care
🇺🇸
Columbus, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸
Cleveland, Ohio, United States
Urology Associates of South Texas, PA
🇺🇸
McAllen, Texas, United States
Mary Crowley Medical Research Center at Sammons Cancer Center
🇺🇸
Dallas, Texas, United States
CCOP - Virginia Mason Research Center
🇺🇸
Seattle, Washington, United States
Hospital Zonal General de Agudos
🇦🇷
Ranelagh, Buenos Aires, Argentina
Unidad Oncologica Del Neuquen
🇦🇷
Neuquen, Argentina
Centro de Oncologia Rosario
🇦🇷
Rosario, Argentina
Clinical Especializada ISIS
🇦🇷
Santa Fe, Argentina
Biocancer Centro de Pesq e Trat de Cancer SA
🇧🇷
Belo-Horizonte, Minas Gerais, Brazil
Instituto Nacional de Cancer
🇧🇷
Rio de Janeiro, Brazil
Hospital Sirio-Libanes
🇧🇷
Sao Paulo, Brazil
Universidade Federal de Sao Paulo
🇧🇷
Sao Paulo, Brazil
McMaster Institute of Urology at St. Joseph Healthcare
🇨🇦
Hamilton, Ontario, Canada
Male Health Centre - Oakville
🇨🇦
Oakville, Ontario, Canada
Hopital Charles Lemoyne
🇨🇦
Greenfield Park, Quebec, Canada
Instituto Alexander Fleming
🇦🇷
Cramer, Buenos Aires, Argentina
North Idaho Urology - Coeur d'Alene
🇺🇸
Coeur d'Alene, Idaho, United States
Regional Urology, LLC
🇺🇸
Shreveport, Louisiana, United States
Complejo Medico de la Policia Federal Argentina
🇦🇷
Buenos Aires, Capital Federal, Argentina
G. Steinhoff Clinical Research
🇨🇦
Victoria, British Columbia, Canada
Male Health Centre - North York
🇨🇦
Toronto, Ontario, Canada
CMX Research, Incorporated
🇨🇦
Oakville, Ontario, Canada
Nucleo de Oncologia da Bahia
🇧🇷
Bahia, Brazil
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸
Bronx, New York, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Urology Associates
🇺🇸
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
Urology San Antonio, PA - Fredericksburg
🇺🇸
San Antonio, Texas, United States
Urological Associates of Lancaster, Limited
🇺🇸
Lancaster, Pennsylvania, United States