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Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) Clinical research trials and Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer). Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) clinical trial. Human subjects frequently get the finest healthcare available for their Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer) condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)  Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
For Condition: stage 4 renal cell cancer,renal clear cell carcinoma,recurrent renal cell cancer,stage 3 renal cell cancer
Status: Recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cellcarcinoma (kidney cancer). PURPOSE: Randomizedphase III trial to compare the effectiveness of interferon alfa-2b with or without bevacizumab in treating patients who have advanced renal cell carcinoma.
Details: OBJECTIVES: Primary - Compare the overall survival of patients with advanced renal cell carcinoma treated with interferon alfa-2b alone or interferon alfa-2b with bevacizumab. Secondary - Compare the time to disease progression and objective response rates in patients treated with these regimens. - Determine the toxicity of interferon alfa-2b in combination with bevacizumab in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior nephrectomy (yes vs no) and number of risk factors for disease progression (0 vs 1-2 vs 3 or more). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive interferon alfa-2b subcutaneously (SC) three times a week. - Arm II: Patients receive interferon alfa-2b as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed renal cell carcinoma (RCC) - Conventional clear cell carcinoma - Metastatic or unresectable disease - The following characteristics and cellular types are excluded: - True papillary - Sarcomatoid features without a clear cell component - Chromophobe - Oncocytoma - Collecting duct tumor - Transitional cell carcinoma - Measurable or nonmeasurable disease, including any of the following: - Unidimensionally measurable lesion at least 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI - The following are considered nonmeasurable disease: - Small lesions - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions - Irradiated lesions, unless progression is documented after radiotherapy - RCC paraffin tissue blocks or unstained slides must be available - No evidence of prior or concurrent CNS metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - No history of clinically significant bleeding Hepatic - AST/ALT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - Bilirubin no greater than 1.5 times ULN Renal - Creatinine no greater than 1.5 times ULN - No proteinuria greater than 1+ - Proteinuria 2+ or greater allowed provided protein is less than 2 g/24-hour urine collection Cardiovascular - No deep venous thrombosis within the past year - No cerebrovascular accident within the past year - No peripheral vascular disease with claudication on less than 1 block - No uncontrolled hypertension defined as blood pressure of 160 mm Hg or greater (systolic) and/or 90 mm Hg or greater (diastolic) while on medication - No New York Heart Association class II-IV congestive heart failure - No angina pectoris requiring nitrate therapy - No myocardial infarction within the past 6 months - No other significant cardiovascular disease Pulmonary - No pulmonary embolus within the past year - No ongoing hemoptysis Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study treatment - No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication - No delayed wound healing, ulcers, or bone fractures - No uncontrolled psychiatric disorder - No other currently active* malignancy except nonmelanoma skin cancer NOTE: *Disease is not considered currently active if patient completed anticancer therapy and is considered to have less than 30% risk of relapse PRIOR CONCURRENT THERAPY: Biologic therapy - No prior systemic immunotherapy for RCC - No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind - No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy - No prior systemic chemotherapy for RCC - No concurrent chemotherapy Endocrine therapy - No concurrent systemic corticosteroid therapy - Topical and inhaled steroids allowed - No concurrent hormones except steroids for adrenal failure or hormones administered for nondisease-related conditions (e.g., insulin for diabetes) Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered - Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated - No concurrent palliative radiotherapy Surgery - At least 4 weeks since prior major surgery and recovered Other - No other prior systemic investigational therapy for RCC - No other prior adjuvant or neoadjuvant systemic therapy for RCC - No concurrent full-dose oral or parenteral anticoagulation* NOTE: *Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianRini, Study Chair, University of California, San Francisco
Veterans Affairs Medical Center - San Francisco *Recruiting*
San Francisco, California, 94121
United States
Recruiting Patricia Cornett 415-221-4810 ext. 3423
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01655
United States
Recruiting Pankaj Bhargava 508-856-6884
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Martin Edelman 410-328-2703
Veterans Affairs Medical Center - San Diego *Recruiting*
San Diego, California, 92161
United States
Recruiting Saeeda Kirmani 619-552-8585 ext. 3356
MBCCOP - Massey Cancer Center *Recruiting*
Richmond, Virginia, 23298-0037
United States
Recruiting John Roberts 804-828-0450
Florida Hospital Cancer Institute *Recruiting*
Orlando, Florida, 32804
United States
Recruiting Jane Crofton 407-303-2090
Saint Anthony Medical Center *Recruiting*
Rockford, Illinois, 61108
United States
Recruiting Richard Nora 815-227-2273
UNMC Eppley Cancer Center at the University of Nebraska Medical Center *Recruiting*
Omaha, Nebraska, 68198-7680
United States
Recruiting Margaret Kessinger 402-559-7511
West Suburban Center for Cancer Care *Recruiting*
River Forest, Illinois, 60305
United States
Recruiting John Showel 708-763-2700
Memorial Regional Hospital Comprehensive Cancer Center *Recruiting*
Hollywood, Florida, 33021
United States
Recruiting Atif Hussein 954-986-6363
Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Thomas Lad 312-996-2046
Veterans Affairs Medical Center - Durham *Recruiting*
Durham, North Carolina, 27705
United States
Recruiting Michael Kelley 919-286-0411
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5000
United States
Recruiting Joseph Drabick 202-782-6751
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-1932
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Keith Shulman 773-564-5022
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Rogerio Lilenbaum 305-674-2625
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-464-8200
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Michael Perry 573-882-4979
Lombardi Cancer Center at Georgetown University Medical Center *Recruiting*
Washington D.C., District of Columbia, 20007
United States
Recruiting Edward Gelmann 202-444-7303
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Daniel Budman 516-562-8958
Northeast Alabama Regional Medical Center *Recruiting*
Anniston, Alabama, 36207
United States
Recruiting Thomas Twele 256-236-2549
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Clifford Hudis 212-639-6483
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting George Canellos 617-632-3470
McGill University *Recruiting*
Montreal, Quebec, H95 3Y7
Canada
Recruiting Simon Tanguay 514-934-8295, ext. 48309
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting Sreenivasa Nattam 219-484-8830
Veterans Affairs Medical Center - Washington, DC *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Steven Krasnow 202-745-8178
Veterans Affairs Medical Center - Las Vegas *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting Chitha Hulugalle 702-696-3000
Baptist Hospital East - Louisville *Recruiting*
Louisville, Kentucky, 40207
United States
Recruiting Daniel Scullin 502-897-1166
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Broward General Medical Center *Recruiting*
Ft. Lauderdale, Florida, 33316
United States
Recruiting Luis Barreras 954-771-0692
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting Howard Ozer 405-271-4022
Vermont Cancer Center at University of Vermont *Recruiting*
Burlington, Vermont, 05401-3498
United States
Recruiting Hyman Muss 802-847-3827
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Debasish Tripathy 214-648-5113
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeffrey Crawford 919-684-5195
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Palm Beach Cancer Institute *Recruiting*
West Palm Beach, Florida, 33401
United States
Recruiting Robert Jacobson 561-366-4150
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Thomas Shea 919-966-7746
Missouri Baptist Cancer Center *Recruiting*
St. Louis, Missouri, 63131
United States
Recruiting Alan Lyss 314-996-5514
FirstHealth Moore Regional Hospital *Recruiting*
Pinehurst, North Carolina, 28374
United States
Recruiting Ellen Willard 910-295-9205
NorthEast Oncology Associates *Recruiting*
Concord, North Carolina, 28025
United States
Recruiting James Wall 704-783-1370
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Hans Grunwald 718-883-4118
Veterans Affairs Medical Center - Asheville *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-299-2540
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Clara Bloomfield 614-293-7518
Veterans Affairs Medical Center - White River Junction *Recruiting*
White River Junction, Vermont, 05009
United States
Recruiting Joseph O'Donnell 802-295-9363 ext. 5480
Veterans Affairs Medical Center - Columbia (Truman Memorial) *Recruiting*
Columbia, Missouri, 65201
United States
Recruiting William Patterson 573-882-6163
Oncology and Hematology Associates of Southwest Virginia, Inc. *Recruiting*
Roanoke, Virginia, 24014
United States
Recruiting Paul Richards 540-982-0237
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Bruce Peterson 612-624-5631
New Hampshire Oncology-Hematology, PA - Hooksett *Recruiting*
Hooksett, New Hampshire, 03106
United States
Recruiting Douglas Weckstein 603-622-6484
New Hanover Regional Medical Center *Recruiting*
Wilmington, North Carolina, 28402-9025
United States
Recruiting Cyrus Kotwall 910-763-4630
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Stephen Seagren 858-657-7020
CCOP - North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8915
Cape Fear Valley Health System *Recruiting*
Fayetteville, North Carolina, 28302-2000
United States
Recruiting Kamal Bakri 910-609-6910
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Alan Venook 800-888-8664
Norris Cotton Cancer Center at Dartmouth Medical School *Recruiting*
Lebanon, New Hampshire, 03756-0002
United States
Recruiting Marc Ernstoff 603-650-5534
Martha Jefferson Hospital *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
Lifespan: The Miriam Hospital *Recruiting*
Providence, Rhode Island, 02906
United States
Recruiting William Sikov 401-793-7151
Western Pennsylvania Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting Richard Shadduck 412-578-4355
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103
United States
Recruiting Edison Catalano 856-342-2506
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Barnes-Jewish Hospital *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Nancy Bartlett 314-747-3000
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1082
United States
Recruiting David Hurd 336-716-2088
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-982-4963
Virginia Oncology Associates - Norfolk *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting Paul Conkling 757-466-8683
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
CCOP - Southern Nevada Cancer Research Foundation *Recruiting*
Las Vegas, Nevada, 89106
United States
Recruiting John Ellerton 702-384-0013
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Lewis Silverman 212-241-5520
St. Mary's Medical Center *Recruiting*
Huntington, West Virginia, 25701
United States
Recruiting Gerrit Kimmey 304-528-4645
Veterans Affairs Medical Center - Minneapolis *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Vicki Morrison 612-725-2000 ext. 4135
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Alan Lefor 310-423-5874
Veterans Affairs Medical Center - Dallas *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Barry Levinson 214-648-4193
Veterans Affairs Medical Center - Buffalo *Recruiting*
Buffalo, New York, 14215
United States
Recruiting Lynn Steinbrenner 716-862-3191
Veterans Affairs Medical Center - Syracuse *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Stephen Graziano 315-476-7461
Additional Information:
Study ID Numbers: CDR0000335292; CAN-NCIC-CLB-90206,CALGB-90206
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072046
Other Renal Clear Cell Carcinoma Studies:
1. SU5416 in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Previous Treatment
2. Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney Cancer
3. Doxorubicin and Gemcitabine in Treating Patients With Locally Recurrent or Metastatic Unresectable Renal Cell Carcinoma (Kidney Cancer)
4. ZD 1839 in Treating Patients With Metastatic Kidney Cancer
5. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung
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Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
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