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

NCT00087022 | Completed Phase 3 Results DMC

• 6 other identifiers: WX-2003-07-HRWILEX-WX-2003-07-HRARISERUCLA-0404015-01CDR0000372830NCI-2012-00491
• Study Type: interventional
• Target: 864
• Locations: 4 countries
• Sites: 56

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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Quality of Life - Global Health Status

  At 12 months

• Pharmacokinetics of WX-G250

  Week 8

Study Arms (2)

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.

Biological: girentuximab

Arm II

PLACEBO COMPARATOR

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

Other: placebo

Interventions

girentuximab BIOLOGICAL

Given IV

Also known as: Rencarex®, cG250 and WX-G250

Arm I

placebo OTHER

Given IV

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Heidelberg Pharma AG: lead

Study Sites (56)

Unknown Facility

Anchorage, Alaska, 99508, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Helen F. Graham Cancer Center at Christiana Hospital

Newark, Delaware, 19718, United States

Location

Atlantic Urological Associates - Daytona Beach

Daytona Beach, Florida, 32114, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

Southeastern Research Group

Tallahassee, Florida, 32308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Augusta Oncology Associates - Walton Way

Augusta, Georgia, 30901, United States

Location

North Idaho Urology - Coeur d'Alene

Coeur d'Alene, Idaho, 83814-2668, United States

Location

Northeast Indiana Urology, PC

Fort Wayne, Indiana, 46804, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Hematology and Oncology Specialists, LLC - Metairie

Metairie, Louisiana, 70006, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Feist-Weiller Cancer Center at Louisiana State University Health Sciences

Shreveport, Louisiana, 71130-3932, United States

Location

Werner-Francis Urology Associates, LLC

Greenbelt, Maryland, 20770, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic Medical Center - Burlington

Burlington, Massachusetts, 01805, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Community Care Physicians, PC at Urological Institute of NENY

Albany, New York, 12209, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Hudson Valley Urology, PC

Poughkeepsie, New York, 12601, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Alliance Urology Specialists - Greensboro

Greensboro, North Carolina, 27403, United States

Location

Carolina BioOncology Institute

Huntersville, North Carolina, 28078, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

Urological Associates of Lancaster, Limited

Lancaster, Pennsylvania, 17604, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Mary Crowley Medical Research Center at Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Urology Associates of South Texas, PA

McAllen, Texas, 78503, United States

Location

Urology San Antonio, PA - Fredericksburg

San Antonio, Texas, 78229, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110, United States

Location

CCOP - Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Instituto Alexander Fleming

Cramer, Buenos Aires, 1426, Argentina

Location

Hospital Zonal General de Agudos

Ranelagh, Buenos Aires, 1886, Argentina

Location

Complejo Medico de la Policia Federal Argentina

Buenos Aires, Buenos Aires F.D., 1424, Argentina

Location

Unidad Oncologica Del Neuquen

Neuquén, Argentina

Location

Centro de Oncologia Rosario

Rosario, 2000, Argentina

Location

Clinical Especializada ISIS

Santa Fe, S300FFV, Argentina

Location

Biocancer Centro de Pesq e Trat de Cancer SA

Belo Horizonte, Minas Gerais, 30240-060, Brazil

Location

Nucleo de Oncologia da Bahia

Bahia, 40170-070, Brazil

Location

Instituto Nacional de Cancer

Rio de Janeiro, 20230-130, Brazil

Location

Hospital Sirio-Libanes

São Paulo, 01308-050, Brazil

Location

Universidade Federal de Sao Paulo

São Paulo, 04023-900, Brazil

Location

G. Steinhoff Clinical Research

Victoria, British Columbia, V8V 3N1, Canada

Location

McMaster Institute of Urology at St. Joseph Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Male Health Centre - Oakville

Oakville, Ontario, L6H 3PI, Canada

Location

CMX Research, Incorporated

Oakville, Ontario, L6J 3J3, Canada

Location

Male Health Centre - North York

Toronto, Ontario, M6A 3B5, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Related Publications (2)

• 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.

  PMID: 27787547 DERIVED

• 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.

  PMID: 27418270 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

G250 monoclonal antibody

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Head of R&D
• Organization: Heidelberg Pharma AG (previously Wilex AG)

info@hdpharma.com

Study Officials

• Pia Kloepfer, MD

  Heidelberg Pharma AG

  STUDY DIRECTOR

• Arie Belldegrun, MD, FACS

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2004
• First Posted: July 12, 2004
• Study Start: July 1, 2004
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 27, 2018
• Results First Posted: September 12, 2018

Record last verified: 2018-10

Locations

CA (6); US (39); BR (5); AR (6)