Phase
Condition
Urothelial Tract Cancer
Kidney Cancer
Renal Cell Carcinoma
Treatment
N/AClinical Study ID
Ages 18-120 All Genders
Study Summary
Eligibility Criteria
Inclusion
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)
Study Design
Study Description
Connect with a study center
Instituto Alexander Fleming
Cramer, Buenos Aires 1426
ArgentinaSite Not Available
Hospital Zonal General de Agudos
Ranelagh, Buenos Aires 1886
ArgentinaSite Not Available
Complejo Medico de la Policia Federal Argentina
Buenos Aires, Capital Federal 1424
ArgentinaSite Not Available
Unidad Oncologica Del Neuquen
Neuquen,
ArgentinaSite Not Available
Centro de Oncologia Rosario
Rosario, 2000
ArgentinaSite Not Available
Clinical Especializada ISIS
Santa Fe, S300FFV
ArgentinaSite Not Available
Biocancer Centro de Pesq e Trat de Cancer SA
Belo-Horizonte, Minas Gerais 30240-060
BrazilSite Not Available
Nucleo de Oncologia da Bahia
Bahia, 40170-070
BrazilSite Not Available
Instituto Nacional de Cancer
Rio de Janeiro, 20230-130
BrazilSite Not Available
Hospital Sirio-Libanes
Sao Paulo, 01308-050
BrazilSite Not Available
Universidade Federal de Sao Paulo
Sao Paulo, 04023-900
BrazilSite Not Available
G. Steinhoff Clinical Research
Victoria, British Columbia V8V 3N1
CanadaSite Not Available
McMaster Institute of Urology at St. Joseph Healthcare
Hamilton, Ontario L8N 4A6
CanadaSite Not Available
CMX Research, Incorporated
Oakville, Ontario L6J 3J3
CanadaSite Not Available
Male Health Centre - Oakville
Oakville, Ontario L6H 3PI
CanadaSite Not Available
Male Health Centre - North York
Toronto, Ontario M6A 3B5
CanadaSite Not Available
Hopital Charles Lemoyne
Greenfield Park, Quebec J4V 2H1
CanadaSite Not Available
Anchorage, Alaska 99508
United StatesSite Not Available
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California 90095-1781
United StatesSite Not Available
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United StatesSite Not Available
Helen F. Graham Cancer Center at Christiana Hospital
Newark, Delaware 19718
United StatesSite Not Available
Atlantic Urological Associates - Daytona Beach
Daytona Beach, Florida 32114
United StatesSite Not Available
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
Southeastern Research Group
Tallahassee, Florida 32308
United StatesSite Not Available
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Augusta Oncology Associates - Walton Way
Augusta, Georgia 30901
United StatesSite Not Available
North Idaho Urology - Coeur d'Alene
Coeur d'Alene, Idaho 83814-2668
United StatesSite Not Available
Northeast Indiana Urology, PC
Fort Wayne, Indiana 46804
United StatesSite Not Available
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa 52242-1002
United StatesSite Not Available
Hematology and Oncology Specialists, LLC - Metairie
Metairie, Louisiana 70006
United StatesSite Not Available
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana 71130-3932
United StatesSite Not Available
Regional Urology, LLC
Shreveport, Louisiana 71106
United StatesSite Not Available
Werner-Francis Urology Associates, LLC
Greenbelt, Maryland 20770
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Lahey Clinic Medical Center - Burlington
Burlington, Massachusetts 01805
United StatesSite Not Available
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Nevada Cancer Institute
Las Vegas, Nevada 89135
United StatesSite Not Available
Community Care Physicians, PC at Urological Institute of NENY
Albany, New York 12209
United StatesSite Not Available
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York 10466
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263-0001
United StatesSite Not Available
AccuMed Research Associates
Garden City, New York 11530
United StatesSite Not Available
Mount Sinai School of Medicine
New York, New York 10029
United StatesSite Not Available
Hudson Valley Urology, PC
Poughkeepsie, New York 12601
United StatesSite Not Available
Alliance Urology Specialists - Greensboro
Greensboro, North Carolina 27403
United StatesSite Not Available
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45219
United StatesSite Not Available
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United StatesSite Not Available
Riverside Methodist Hospital Cancer Care
Columbus, Ohio 43214-3998
United StatesSite Not Available
Urological Associates of Lancaster, Limited
Lancaster, Pennsylvania 17604
United StatesSite Not Available
Urology Associates
Nashville, Tennessee 37209
United StatesSite Not Available
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6838
United StatesSite Not Available
Mary Crowley Medical Research Center at Sammons Cancer Center
Dallas, Texas 75246
United StatesSite Not Available
Urology Associates of South Texas, PA
McAllen, Texas 78503
United StatesSite Not Available
Urology San Antonio, PA - Fredericksburg
San Antonio, Texas 78229
United StatesSite Not Available
Vermont Cancer Center at University of Vermont
Burlington, Vermont 05405-0110
United StatesSite Not Available
CCOP - Virginia Mason Research Center
Seattle, Washington 98101
United StatesSite Not Available
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