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

Phase 3

Completed

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

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.

Locations (55): Jonsson Comprehensive Cancer Center at UCLA
🇺🇸
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, 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
Southeastern Research Group
🇺🇸
Tallahassee, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸
Atlanta, Georgia, United States
Augusta Oncology Associates - Walton Way
🇺🇸
Augusta, Georgia, United States
North Idaho Urology - Coeur d'Alene
🇺🇸
Coeur d'Alene, Idaho, United States
Northeast Indiana Urology, PC
🇺🇸
Fort Wayne, Indiana, United States
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Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States