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)
18 Years
N/A
Both
Kidney Cancer
Trial Information
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)
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Outcome Time Frame:
Local 360 DFS events
Safety Issue:
No
Principal Investigator
Pia Kloepfer, MD
Investigator Role:
Study Director
Investigator Affiliation:
Wilex
Authority:
United States: Food and Drug Administration
Study ID:
WX-2003-07-HR
NCT ID:
NCT00087022
Start Date:
July 2004
Completion Date:
October 2012
Related Keywords:
- Kidney Cancer
- 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
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Lahey Clinic Medical Center - Burlington | Burlington, Massachusetts 01805 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | Shreveport, Louisiana 71130-3932 |
| Augusta Oncology Associates - Walton Way | Augusta, Georgia 30901 |
| Anchorage, Alaska | |
| AccuMed Research Associates | Garden City, New York 11530 |
| Urology Associates | Nashville, Tennessee 37209 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Helen F. Graham Cancer Center at Christiana Hospital | Newark, Delaware 19718 |
| Atlantic Urological Associates - Daytona Beach | Daytona Beach, Florida 32114 |
| Southeastern Research Group | Tallahassee, Florida 32308 |
| North Idaho Urology - Coeur d'Alene | Coeur d'Alene, Idaho 83814-2668 |
| Northeast Indiana Urology, PC | Fort Wayne, Indiana 46804 |
| Hematology and Oncology Specialists, LLC - Metairie | Metairie, Louisiana 70006 |
| Regional Urology, LLC | Shreveport, Louisiana 71106 |
| Werner-Francis Urology Associates, LLC | Greenbelt, Maryland 20770 |
| Community Care Physicians, PC at Urological Institute of NENY | Albany, New York 12209 |
| Hudson Valley Urology, PC | Poughkeepsie, New York 12601 |
| Alliance Urology Specialists - Greensboro | Greensboro, North Carolina 27403 |
| Carolina BioOncology Institute | Huntersville, North Carolina 28078 |
| Urological Associates of Lancaster, Limited | Lancaster, Pennsylvania 17604 |
| Mary Crowley Medical Research Center at Sammons Cancer Center | Dallas, Texas 75246 |
| Urology Associates of South Texas, PA | McAllen, Texas 78503 |
| Urology San Antonio, PA - Fredericksburg | San Antonio, Texas 78229 |
