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

Kidney Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087022
• Other study ID #: WX-2003-07-HR
• Secondary ID: WILEX-WX-2003-07
• Status: Completed
• Phase: Phase 3
• Start date: July 2004
• Est. completion date: October 2012

Study information

• Verified date: October 2018
• Source: Wilex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00209183

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• girentuximab
Given IV

Other:
• placebo
Given IV

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wilex

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free Survival	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.	Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Primary	Overall Survival	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.	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)
Secondary	Quality of Life - Global Health Status	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.	At 12 months
Secondary	Pharmacokinetics of WX-G250	Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).	Week 8