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Interferon Alfacon-1 Injection |
Infergen |
Clinical Trial: Interferon alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
This study is currently recruiting patients.
Purpose
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 cell carcinoma (kidney cancer).
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa-2b with or without bevacizumab in treating patients who have advanced renal cell carcinoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stage IV Renal Cell Cancer renal clear cell carcinoma recurrent renal cell cancer | Drug: bevacizumab Drug: interferon alfa Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: cytokine therapy Procedure: growth factor antagonist therapy Procedure: interferon therapy Procedure: monoclonal antibody therapy | Phase III |
MedlinePlus related topics: Cancer; Kidney Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Interferon alfa-2b With or Without Bevacizumab in Patients With Advanced Renal Cell Carcinoma
Further Study 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 and then annually for up to 10 years after study entry.
PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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 ≥ 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 ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- No history of clinically significant bleeding
Hepatic
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
- No proteinuria > 1+
- Proteinuria ≥ 2+ allowed provided protein is < 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 < 1 block
- No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (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 < 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 except the following:
- Topical and inhaled steroids
- Replacement therapy for adrenal insufficiency
- No concurrent hormones except those 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
Location and Contact Information
Alabama
Northeast Alabama Regional Medical Center, Anniston, Alabama, 36207, United States; Recruiting
Thomas W. Twele, MD 256-236-2549
California
Naval Medical Center - San Diego, San Diego, California, 92134-3202, United States; Recruiting
Preston Gable, MD 619-532-7303 pgable@nmcsd.med.navy.mil
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, 92093-0658, United States; Recruiting
Stephen L. Seagren, MD 619-543-5303
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Alan T. Lefor, MD 310-423-5874 Alan.Lefor@cshs.org
UCSF Comprehensive Cancer Center, San Francisco, California, 94115, United States; Recruiting
Alan Paul Venook, MD 800-888-8664 venook@cc.ucsf.edu
Veterans Affairs Medical Center - San Diego, San Diego, California, 92161, United States; Recruiting
Saeeda Kirmani, MD 619-552-8585 ext. 3356 skirmani@ucsd.edu
Veterans Affairs Medical Center - San Francisco, San Francisco, California, 94121, United States; Recruiting
Patricia A. Cornett, MD 415-221-4810 ext. 3423 patricia.cornett@med.va.gov
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Edward P. Gelmann, MD 202-444-7303 gelmanne@georgetown.edu
Veterans Affairs Medical Center - Washington, DC, Washington, District of Columbia, 20422, United States; Recruiting
Steven H. Krasnow, MD 202-745-8178 krasnow.steven@washington.va.gov
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
Thomas Joseph Reid, MD, PhD, FACP 202-782-5762 thomas.reid@na.amedd.army.mil
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Luis Ramon Barreras, MD, FACP 954-771-0692
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States; Recruiting
Rogerio C. Lilenbaum, MD 305-674-2625
Memorial Cancer Institute at Memorial Regional Hospital, Hollywood, Florida, 33021, United States; Recruiting
Atif M. Hussein, MD 954-986-6363
Palm Beach Cancer Institute - West Palm Beach, West Palm Beach, Florida, 33401, United States; Recruiting
Robert J. Jacobson, MB, ChB, FACP, FRCP(C) 561-366-4150
Illinois
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
CCOP - Illinois Oncology Research Association, Peoria, Illinois, 61615-7828, United States; Recruiting
John W. Kugler, MD 309-243-3605
La Grange Oncology Associates, La Grange, Illinois, 60525, United States; Recruiting
James E. Hannigan, MD 708-579-3418 jhannigan@lagrangeoncology.com
Louis A. Weiss Memorial Hospital, Chicago, Illinois, 60640, United States; Recruiting
Keith L. Shulman, MD 773-564-5022 KShulman@weisshospital.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Swedish-American Regional Cancer Center, Rockford, Illinois, 61104-2315, United States; Recruiting
Lori Kline, RN, BS 815-489-4413 lkline@swedishamerican.org
University of Chicago Cancer Research Center, Chicago, Illinois, 60637-1470, United States; Recruiting
Karen Wendling 773-834-7424
Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois, 60612, United States; Recruiting
Thomas E. Lad, MD 312-996-2046
West Suburban Center for Cancer Care, River Forest, Illinois, 60305, United States; Recruiting
John L. Showel, MD 708-763-2700 doc.shoj@wsmc.org
Indiana
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, 46601, United States; Recruiting
Rafat H. Ansari, MD, FACP 574-284-7977
Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, 46885-5099, United States; Recruiting
Sreenivasa Rao Nattam, MD 260-484-8830 ledgar@fwmoh.com
Iowa
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Gerald H. Clamon, MD 319-356-8110
Kentucky
Baptist Hospital East - Louisville, Louisville, Kentucky, 40207, United States; Recruiting
Daniel C. Scullin, MD 502-897-1166
Maryland
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, 21201, United States; Recruiting
Martin J. Edelman, MD 410-328-2703 medelman@umm.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Michael Benjamin Atkins, MD 617-667-1930
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, 02115, United States; Recruiting
George P. Canellos, MD 617-632-3470 george_canellos@dfci.harvard.edu
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01655, United States; Recruiting
Pankaj Bhargava 508-856-6884 bhargavp@ummhc.org
Michigan
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, 49085, United States; Recruiting
Cynthia Bender, BA, CRA 269-985-4516 cbender@lakelandregional.org
Minnesota
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Bruce A. Peterson, MD 612-624-5631
Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota, 55417, United States; Recruiting
Vicki A. Morrison, MD 612-467-4135 morri002@tc.umn.edu
Missouri
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, 65203, United States; Recruiting
Michael C. Perry, MD 573-882-4979 perrym@health.missouri.edu
Missouri Baptist Cancer Center, Saint Louis, Missouri, 63131, United States; Recruiting
Alan Philip Lyss, MD 314-996-5514 alyss@bjc.org
Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis, Missouri, 63110, United States; Recruiting
Nancy L. Bartlett, MD 314-362-4843
Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia, Missouri, 65201, United States; Recruiting
William P. Patterson, MD 573-882-6163
Nebraska
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting
Margaret Anne Kessinger, MD 402-559-7511 makessin@unmc.edu
Nevada
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106, United States; Recruiting
John Allan Ellerton, MD, CM 702-384-0013 k.vanwagenen@sncrf.org
Veterans Affairs Medical Center - Las Vegas, Las Vegas, Nevada, 89106, United States; Recruiting
Chitha R. Hulugalle, MD 702-696-3000
New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, 03106, United States; Recruiting
Douglas Jay Weckstein, MD 603-622-6484 d.weckstein@nhoh.com
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756-0002, United States; Recruiting
Marc Stuart Ernstoff, MD 603-650-5534 Marc.S.Ernstoff@Hitchcock.org
New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital, Camden, New Jersey, 08103, United States; Recruiting
Edison Catalano, MD 856-342-2506
New York
CCOP - North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Vincent P. Vinciguerra, MD 516-562-8954
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., East Syracuse, New York, 13057, United States; Recruiting
Jeffrey J. Kirshner, MD 315-472-7504
Lipson Cancer and Blood Center at Rochester General Hospital, Rochester, New York, 14621, United States; Recruiting
Peter Bushunow, MD 585-922-4020 peter.bushunow@viahealth.org
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Clifford A. Hudis, MD 212-639-6483
Mount Sinai Medical Center, New York, New York, 10029, United States; Recruiting
Lewis R. Silverman, MD 212-241-5520 lewis.silverman@mssm.edu
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Scott Wadler, MD 212-746-2844 scw2004@med.cornell.edu
North Shore University Hospital, Manhasset, New York, 11030, United States; Recruiting
Daniel R. Budman, MD 516-562-8958
Queens Cancer Center of Queens Hospital, Jamaica, New York, 11432, United States; Recruiting
Hans W. Grunwald, MD 718-883-4118 hans.grunwald@mssm.edu
Roswell Park Cancer Institute, Buffalo, New York, 14263-0001, United States; Recruiting
Ellis G. Levine, MD 716-845-8547
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-464-8200 grazians@upstate.edu
Veterans Affairs Medical Center - Buffalo, Buffalo, New York, 14215, United States; Recruiting
Lynn Marie Steinbrenner, MD 716-862-3191 lynn.steinbrenner@med.va.gov
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, 13210, United States; Recruiting
Stephen L. Graziano, MD 315-476-7461
North Carolina
Cape Fear Valley Medical Center, Fayetteville, North Carolina, 28302-2000, United States; Recruiting
Kamal M. Bakri, MD 910-609-6910
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, 27534-9479, United States; Recruiting
James N. Atkins, MD 336-777-3088
Comprehensive Cancer Center at Moore Regional Hospital, Pinehurst, North Carolina, 28374, United States; Recruiting
Ellen M. Willard, MD 910-295-9205
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
David Duane Hurd, MD 336-716-2088 dhurd@wfubmc.edu
Duke Comprehensive Cancer Center, Durham, North Carolina, 27710, United States; Recruiting
Jeffrey Crawford, MD 919-684-5621 crawf006@mc.duke.edu
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7295, United States; Recruiting
Thomas C. Shea, MD 919-966-7746 sheaT@med.unc.edu
NorthEast Oncology Associates - Concord, Concord, North Carolina, 28025, United States; Recruiting
James Grier Wall, MD 704-783-1370 jwall@northeastmedical.org
Veterans Affairs Medical Center - Asheville, Asheville, North Carolina, 28805-9913, United States; Recruiting
John C. Lucke, MD 828-299-2540
Veterans Affairs Medical Center - Durham, Durham, North Carolina, 27705, United States; Recruiting
Michael J. Kelley, MD 919-286-0411 ext. 7326
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, 28402-9025, United States; Recruiting
Cyrus A. Kotwall, MD 910-763-4630
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Clara D. Bloomfield, MD 614-293-7518 bloomfield-1@medctr.osu.edu
Oklahoma
Oklahoma University Medical Center, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Howard Ozer, MD, PhD 405-271-4022
Pennsylvania
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, 15224, United States; Recruiting
Richard K. Shadduck, MD 412-578-4355 rshadduck@msn.com
Rhode Island
Miriam Hospital at Lifespan, Providence, Rhode Island, 02906, United States; Recruiting
William M. Sikov, MD 401-793-7151 wsikov@lifespan.org
Texas
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-8852, United States; Recruiting
Debasish Tripathy, MD 214-648-7705
Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75219, United States; Recruiting
Jonathan Dowell, MD 214-857-0737
Vermont
Vermont Cancer Center at University of Vermont, Burlington, Vermont, 05401-3498, United States; Recruiting
Hyman Bernard Muss, MD 802-847-3827
Virginia
Martha Jefferson Hospital, Charlottesville, Virginia, 22902, United States; Recruiting
Stefan M. Gorsch, MD 434-982-8410
MBCCOP - Massey Cancer Center, Richmond, Virginia, 23298-0037, United States; Recruiting
John D. Roberts, MD 804-828-0450
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, 24014, United States; Recruiting
Paul D. Richards, MD 540-982-0237 paul.richards@usoncology.com
Virginia Oncology Associates - Norfolk, Norfolk, Virginia, 23502, United States; Recruiting
Paul R. Conkling, MD 757-466-8683
West Virginia
St. Mary's Medical Center, Huntington, West Virginia, 25701, United States; Recruiting
Gerrit A. Kimmey, MD 304-528-4645
Canada, Quebec
McGill Cancer Centre, Montreal, Quebec, HG3 1AY, Canada; Recruiting
Simon Tanguay, MD 514-934-8535 simon.tanguay@mcgill.ca
Study chairs or principal investigators
Brian I. Rini, MD, Study Chair, University of California, San Francisco
Simon Tanguay, MD, Study Chair, McGill Cancer Centre
Janice P. Dutcher, MD, Study Chair, Comprehensive Cancer Center at Our Lady of Mercy Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Publications
Rini BI, Halabi S, Taylor J, Small EJ, Schilsky RL; Cancer and Leukemia Group B. Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma. Clin Cancer Res. 2004 Apr 15;10(8):2584-6.
Study ID Numbers: CDR0000335292; CALGB-90206; CAN-NCIC-CLB-90206; ECOG-CALGB-90206; NCT00072046
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072046
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: November 4, 2003
ClinicalTrials.gov Identifier: NCT00072046
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Infergen (Drug Digest)
- Interferon Alfacon-1 Injection (Drug Digest)
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