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

NCT ID: NCT00087022

Last Updated: 2018-11-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 864 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2012-10-31

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.

Conditions

Kidney Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm I

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

Group Type: EXPERIMENTAL

girentuximab

Intervention Type: BIOLOGICAL

Given IV

Arm II

Patients receive placebo IV over 15 minutes once weekly for 24 weeks.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given IV

Interventions

girentuximab

Given IV

Intervention Type: BIOLOGICAL

placebo

Given IV

Intervention Type: OTHER

Other Intervention Names

Rencarex®, cG250 and WX-G250

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pia Kloepfer, MD

Role: STUDY_DIRECTOR

Heidelberg Pharma AG

Arie Belldegrun, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Anchorage, Alaska, United States

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

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Hematology and Oncology Specialists, LLC - Metairie

Metairie, Louisiana, United States

Regional Urology, LLC

Shreveport, Louisiana, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, United States

Werner-Francis Urology Associates, LLC

Greenbelt, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Nevada Cancer Institute

Las Vegas, Nevada, 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

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, United States

Alliance Urology Specialists - Greensboro

Greensboro, North Carolina, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Urological Associates of Lancaster, Limited

Lancaster, Pennsylvania, United States

Urology Associates

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, United States

Urology Associates of South Texas, PA

McAllen, Texas, United States

Urology San Antonio, PA - Fredericksburg

San Antonio, Texas, United States

Vermont Cancer Center at University of Vermont

Burlington, Vermont, United States

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Instituto Alexander Fleming

Cramer, Buenos Aires, Argentina

Hospital Zonal General de Agudos

Ranelagh, Buenos Aires, Argentina

Complejo Medico de la Policia Federal Argentina

Buenos Aires, Buenos Aires F.D., Argentina

Unidad Oncologica Del Neuquen

Neuquén, , 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

Nucleo de Oncologia da Bahia

Bahia, , Brazil

Instituto Nacional de Cancer

Rio de Janeiro, , Brazil

Hospital Sirio-Libanes

São Paulo, , Brazil

Universidade Federal de Sao Paulo

São Paulo, , Brazil

G. Steinhoff Clinical Research

Victoria, British Columbia, Canada

McMaster Institute of Urology at St. Joseph Healthcare

Hamilton, Ontario, Canada

Male Health Centre - Oakville

Oakville, Ontario, Canada

CMX Research, Incorporated

Oakville, Ontario, Canada

Male Health Centre - North York

Toronto, Ontario, Canada

Hopital Charles Lemoyne

Greenfield Park, Quebec, Canada

Countries

United States; Argentina; Brazil; Canada

References

Chamie K, Donin NM, Klopfer P, Bevan P, Fall B, Wilhelm O, Storkel S, Said J, Gambla M, Hawkins RE, Jankilevich G, Kapoor A, Kopyltsov E, Staehler M, Taari K, Wainstein AJA, Pantuck AJ, Belldegrun AS. Adjuvant Weekly Girentuximab Following Nephrectomy for High-Risk Renal Cell Carcinoma: The ARISER Randomized Clinical Trial. JAMA Oncol. 2017 Jul 1;3(7):913-920. doi: 10.1001/jamaoncol.2016.4419.

Reference Type: DERIVED

PMID: 27787547 (View on PubMed)

Donin NM, Pantuck A, Klopfer P, Bevan P, Fall B, Said J, Belldegrun AS, Chamie K. Body Mass Index and Survival in a Prospective Randomized Trial of Localized High-Risk Renal Cell Carcinoma. Cancer Epidemiol Biomarkers Prev. 2016 Sep;25(9):1326-32. doi: 10.1158/1055-9965.EPI-16-0226. Epub 2016 Jul 14.

Reference Type: DERIVED

PMID: 27418270 (View on PubMed)

Other Identifiers

WILEX-WX-2003-07-HR

Identifier Type: OTHER

Identifier Source: secondary_id

ARISER

Identifier Type: OTHER

Identifier Source: secondary_id

UCLA-0404015-01

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000372830

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-00491

Identifier Type: REGISTRY

Identifier Source: secondary_id

WX-2003-07-HR

Identifier Type: -

Identifier Source: org_study_id

NCT00209183

Identifier Type: -

Identifier Source: nct_alias