Kidney CancerPhase 3NCT00087022
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
A Phase 3 study testing girentuximab in people with Kidney Cancer, run by Heidelberg Pharma AG at 56 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- girentuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 864 participants
- Where
- 56 sitesin 4 countries
- Study dates
- Jul 2004to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
56 sites in 4 countries.
56 sites in 4 countries
United States39 sites
Community Care Physicians, PC at Urological Institute of NENY
Albany, New York, 12209
Study site
Anchorage, Alaska, 99508
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Augusta Oncology Associates - Walton Way
Augusta, Georgia, 30901
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts, 01805
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05405-0110
University of Cincinnati
Cincinnati, Ohio, 45219
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
North Idaho Urology - Coeur d'Alene
Coeur d'Alene, Idaho, 83814-2668
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998
Mary Crowley Medical Research Center at Sammons Cancer Center
Dallas, Texas, 75246
Atlantic Urological Associates - Daytona Beach
Daytona Beach, Florida, 32114
Northeast Indiana Urology, PC
Fort Wayne, Indiana, 46804
AccuMed Research Associates
Garden City, New York, 11530
Werner-Francis Urology Associates, LLC
Greenbelt, Maryland, 20770
Alliance Urology Specialists - Greensboro
Greensboro, North Carolina, 27403
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Urological Associates of Lancaster, Limited
Lancaster, Pennsylvania, 17604
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Urology Associates of South Texas, PA
McAllen, Texas, 78503
Hematology and Oncology Specialists, LLC - Metairie
Metairie, Louisiana, 70006
Urology Associates
Nashville, Tennessee, 37209
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
Mount Sinai School of Medicine
New York, New York, 10029
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware, 19718
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Urology San Antonio, PA - Fredericksburg
San Antonio, Texas, 78229
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Regional Urology, LLC
Shreveport, Louisiana, 71106
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, 71130-3932
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110
Southeastern Research Group
Tallahassee, Florida, 32308
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
Argentina6 sites
Complejo Medico de la Policia Federal Argentina
Buenos Aires, Buenos Aires F.D., 1424
Instituto Alexander Fleming
Cramer, Buenos Aires, 1426
Unidad Oncologica Del Neuquen
Neuquén
Hospital Zonal General de Agudos
Ranelagh, Buenos Aires, 1886
Centro de Oncologia Rosario
Rosario, 2000
Clinical Especializada ISIS
Santa Fe, S300FFV
Canada6 sites
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
McMaster Institute of Urology at St. Joseph Healthcare
Hamilton, Ontario, L8N 4A6
Male Health Centre - Oakville
Oakville, Ontario, L6H 3PI
CMX Research, Incorporated
Oakville, Ontario, L6J 3J3
Male Health Centre - North York
Toronto, Ontario, M6A 3B5
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1
Brazil5 sites
Nucleo de Oncologia da Bahia
Bahia, 40170-070
Biocancer Centro de Pesq e Trat de Cancer SA
Belo Horizonte, Minas Gerais, 30240-060
Instituto Nacional de Cancer
Rio de Janeiro, 20230-130
Hospital Sirio-Libanes
São Paulo, 01308-050
Universidade Federal de Sao Paulo
São Paulo, 04023-900
About this study
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)
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.
Read the 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
- Being tested
- girentuximab, placebo
- 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
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
girentuximabBiological
Also called Rencarex®, cG250 and WX-G250
Given IV
placeboOther
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks. Receives: Biological: girentuximab |
| Arm II | Placebo comparator | Patients receive placebo IV over 15 minutes once weekly for 24 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)
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.
Measured: 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 outcomes (2)
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.
Measured: At 12 months
Pharmacokinetics of WX-G250
Quantitative determination of cG250 (Girentuximab) trough serum profiles at week 8 (steady state concentration).
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2004 (estimated)
- Study startJul 2004
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pia Kloepfer, MD, Study director, Heidelberg Pharma AGArie Belldegrun, MD, FACS, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087022
- Sponsor's protocol ID
- WX-2003-07-HR
- Other IDs
- WILEX-WX-2003-07-HR, ARISER, UCLA-0404015-01, CDR0000372830, NCI-2012-00491
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2004
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27787547Donin 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.
PubMed 27418270
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00087022
- Acronym / sponsor ID
- WX-2003-07-HR
- Conditions
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 12 Jul 2004 (estimated)
- Results
- Posted 12 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: girentuximabPatients receive monoclonal chimeric antibody cG250 (synonym names: Rencarex®, girentuximab, and WX-G250) IV over 15 minutes once weekly for 24 weeks. |
| Arm II | Placebo comparator | Other: placeboPatients receive placebo IV over 15 minutes once weekly for 24 weeks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| girentuximabAlso: Rencarex®, cG250 and WX-G250Given IV | Biological | Arm I |
| placeboGiven IV | Other | Arm II |
Primary outcome
Disease-free Survival
Time frame: 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
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)
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.
2 secondary outcomes
Quality of Life - Global Health Status
Time frame: At 12 months
Pharmacokinetics of WX-G250
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27787547Chamie 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.
- Derived from this study: PubMed 27418270Donin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Kloepfer, MD study director
Heidelberg Pharma AG
Arie Belldegrun, MD, FACS principal investigator
Jonsson Comprehensive Cancer Center
56 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing girentuximab in people with Kidney Cancer, run by Heidelberg Pharma AG at 56 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Argentina, Canada, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (time frame: Until signs of recurrence or until 360 local DFS events have occurred (median follow-up of 4.5 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00087022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.