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

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
girentuximab
placebo
Sponsored by
Heidelberg Pharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring clear cell renal cell carcinoma, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Helen F. Graham Cancer Center at Christiana Hospital
  • Atlantic Urological Associates - Daytona Beach
  • Mayo Clinic - Jacksonville
  • Southeastern Research Group
  • Winship Cancer Institute of Emory University
  • Augusta Oncology Associates - Walton Way
  • North Idaho Urology - Coeur d'Alene
  • Northeast Indiana Urology, PC
  • Holden Comprehensive Cancer Center at University of Iowa
  • Hematology and Oncology Specialists, LLC - Metairie
  • Regional Urology, LLC
  • Feist-Weiller Cancer Center at Louisiana State University Health Sciences
  • Werner-Francis Urology Associates, LLC
  • Beth Israel Deaconess Medical Center
  • Lahey Clinic Medical Center - Burlington
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
  • Nevada Cancer Institute
  • Community Care Physicians, PC at Urological Institute of NENY
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • Roswell Park Cancer Institute
  • AccuMed Research Associates
  • Mount Sinai School of Medicine
  • Hudson Valley Urology, PC
  • Alliance Urology Specialists - Greensboro
  • Carolina BioOncology Institute
  • University of Cincinnati
  • Cleveland Clinic Taussig Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • Urological Associates of Lancaster, Limited
  • Urology Associates
  • Vanderbilt-Ingram Cancer Center
  • Mary Crowley Medical Research Center at Sammons Cancer Center
  • Urology Associates of South Texas, PA
  • Urology San Antonio, PA - Fredericksburg
  • Vermont Cancer Center at University of Vermont
  • CCOP - Virginia Mason Research Center
  • Instituto Alexander Fleming
  • Hospital Zonal General de Agudos
  • Complejo Medico de la Policia Federal Argentina
  • Unidad Oncologica Del Neuquen
  • Centro de Oncologia Rosario
  • Clinical Especializada ISIS
  • Biocancer Centro de Pesq e Trat de Cancer SA
  • Nucleo de Oncologia da Bahia
  • Instituto Nacional de Cancer
  • Hospital Sirio-Libanes
  • Universidade Federal de Sao Paulo
  • G. Steinhoff Clinical Research
  • McMaster Institute of Urology at St. Joseph Healthcare
  • Male Health Centre - Oakville
  • CMX Research, Incorporated
  • Male Health Centre - North York
  • Hopital Charles Lemoyne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm I

Arm II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Pharmacokinetics of WX-G250
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).

Full Information

First Posted
July 8, 2004
Last Updated
October 31, 2018
Sponsor
Heidelberg Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT00087022
Brief Title
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heidelberg Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
clear cell renal cell carcinoma, stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
864 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo IV over 15 minutes once weekly for 24 weeks.
Intervention Type
Biological
Intervention Name(s)
girentuximab
Other Intervention Name(s)
Rencarex®, cG250 and WX-G250
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Disease-free Survival
Description
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.
Time Frame
Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
Title
Overall Survival
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Quality of Life - Global Health Status
Description
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.
Time Frame
At 12 months
Title
Pharmacokinetics of WX-G250
Description
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pia Kloepfer, MD
Organizational Affiliation
Heidelberg Pharma AG
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arie Belldegrun, MD, FACS
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Helen F. Graham Cancer Center at Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Atlantic Urological Associates - Daytona Beach
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Southeastern Research Group
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta Oncology Associates - Walton Way
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
North Idaho Urology - Coeur d'Alene
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814-2668
Country
United States
Facility Name
Northeast Indiana Urology, PC
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC - Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Werner-Francis Urology Associates, LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic Medical Center - Burlington
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Community Care Physicians, PC at Urological Institute of NENY
City
Albany
State/Province
New York
ZIP/Postal Code
12209
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Hudson Valley Urology, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Alliance Urology Specialists - Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Carolina BioOncology Institute
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3998
Country
United States
Facility Name
Urological Associates of Lancaster, Limited
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
Mary Crowley Medical Research Center at Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Urology Associates of South Texas, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Urology San Antonio, PA - Fredericksburg
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Vermont Cancer Center at University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405-0110
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Instituto Alexander Fleming
City
Cramer
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Hospital Zonal General de Agudos
City
Ranelagh
State/Province
Buenos Aires
ZIP/Postal Code
1886
Country
Argentina
Facility Name
Complejo Medico de la Policia Federal Argentina
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
1424
Country
Argentina
Facility Name
Unidad Oncologica Del Neuquen
City
Neuquen
Country
Argentina
Facility Name
Centro de Oncologia Rosario
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Clinical Especializada ISIS
City
Santa Fe
ZIP/Postal Code
S300FFV
Country
Argentina
Facility Name
Biocancer Centro de Pesq e Trat de Cancer SA
City
Belo-Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30240-060
Country
Brazil
Facility Name
Nucleo de Oncologia da Bahia
City
Bahia
ZIP/Postal Code
40170-070
Country
Brazil
Facility Name
Instituto Nacional de Cancer
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Hospital Sirio-Libanes
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
G. Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
McMaster Institute of Urology at St. Joseph Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Male Health Centre - Oakville
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3PI
Country
Canada
Facility Name
CMX Research, Incorporated
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 3J3
Country
Canada
Facility Name
Male Health Centre - North York
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27787547
Citation
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.
Results Reference
derived
PubMed Identifier
27418270
Citation
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.
Results Reference
derived

Learn more about this trial

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

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