In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive18 and overNCI, OtherRTOG-1205
NCI-2012-01732, U10CA021661, NCT01730950

Trial Description

Summary

This randomized phase II trial studies how well bevacizumab with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma

Further Study Information

PRIMARY OBJECTIVES:

I. To establish an improvement in overall survival in recurrent glioblastoma (GBM) patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.

SECONDARY OBJECTIVES:

I. To estimate and compare the rate of objective response in patients with measurable disease.

II. To estimate and compare the 6-month progression-free survival rate. III. To estimate and compare progression-free survival. IV. To estimate and compare the rate of treatment adverse events. V. To estimate and compare the rate of grade 3+ acute or delayed central nervous system (CNS) toxicity.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes every 2 weeks.

ARM II: Patients receive bevacizumab as patients in arm I and undergo radiation therapy using intensity-modulated radiation therapy (IMRT), 3-dimensional conformal radiation therapy (3D-CRT), or proton beam radiation therapy (RT) 5 days a week for 2 weeks.

In both arms, courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, every 6 months for 1 year and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Histopathologically proven diagnosis of glioblastoma or variants (gliosarcoma, giant cell glioblastoma etc); patients will be eligible if the original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made
  • Patients who did not have recent surgery for their glioblastoma must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced magnetic resonance imaging (MRI) scan (or computed tomography [CT] scan for patients with non-compatible devices) CT scan within 21 days prior to registration
  • Patients also must have passed an interval of 6 months or greater between completion of prior radiotherapy and registration; if patients have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria:
  • New areas of tumor outside the original radiotherapy fields as determined by the investigator, or
  • Histologic confirmation of tumor through biopsy or resection, or
  • Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of registration AND an interval of at least 90 days between completion of radiotherapy and registration
  • Patients unable to undergo MR imaging because of non-compatible devices can be enrolled provided CT scans are obtained and are of sufficient quality; patients without non-compatible devices may not use CT scans performed to meet this requirement
  • Prior history of standard dose CNS radiation of 60 Gy in 30 fractions or 59.4 Gy in 1.8 Gy fractions, or equivalent or lower doses
  • Patients who have received prior treatment with non-standard radiation therapy (RT) dose and fractionation, interstitial brachytherapy, stereotactic radiosurgery, etc. are eligible
  • Patients must have recovered from the toxic effects of prior therapy, and there must be a minimum time of 28 days prior to registration from the administration of any investigational agent or prior cytotoxic therapy with the following exceptions:
  • 14 days from administration of vincristine
  • 42 days from administration of nitrosoureas
  • 21 days from administration of procarbazine
  • Patients having undergone recent resection of their glioblastoma (within 5 weeks prior to registration) must have recovered from the effects of surgery; for CNS related core or needle biopsies, a minimum of 7 days must have elapsed prior to registration
  • Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative MRI scan (or CT scan for patients with non-compatible devices) must be performed within 30 days prior to registration and should be within 96 hours post surgery (although 24 hours would be optimum)
  • History/physical examination, including neurologic examination, within 14 days prior to registration
  • Karnofsky performance status >= 60 within 14 days prior to registration
  • Complete blood count (CBC)/differential obtained within 14 days prior to registration, with adequate bone marrow function
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 75,000 cells/mm^3
  • Hemoglobin >= 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 9.0 g/dl is acceptable)
  • Total bilirubin =< 2.0 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) or aspartate aminotransferase (AST) =< 2.5 times the upper limit of normal
  • Serum creatinine =< 1.8 mg/dL
  • Urine protein creatinine (UPC) ratio >= 1.0 within 14 days prior to registration OR urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
  • Note: UPC ratio of spot urine is an estimation of the 24-hour urine protein excretion; a UPC ratio of 1 is roughly equivalent to a 24-hour urine protein of 1 gm; UPC ratio is calculated using one of the following formulas:
  • [urine protein]/[urine creatinine]: if both protein and creatinine are reported in mg/dL
  • [(urine protein) x 0.088]/[urine creatinine]: if urine creatinine is reported in mmol/L
  • Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy test must be done within 14 days prior to registration; effective contraception (men and women) must be used in patients of child-bearing potential while on trial and for 6 months after
  • Patients on full-dose anticoagulants (e.g., warfarin or low molecular weigh [LMW] heparin) must meet both of the following criteria:
  • No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • In-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  • Patient must be able to provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • More than three relapses
  • Infratentorial or leptomeningeal evidence of recurrent disease
  • Recurrent or persistent tumor greater than 6 cm in maximum diameter
  • Prior therapy with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Severe, active co-morbidity, defined as follows:
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  • Transmural myocardial infarction within the last 6 months prior to registration
  • History of stroke or transient ischemic attack within 6 months prior to registration
  • Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
  • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function other than screening panel and coagulation parameters are not required for entry into this protocol
  • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive; protocol specific requirements may also exclude immuno-compromised patients
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
  • Prior allergic reaction to the study drug (bevacizumab)
  • Prior history of hypertensive crisis or hypertensive encephalopathy
  • History of a non-healing wound, ulcer, or bone fracture within 90 days (3 months) prior to registration
  • Gastrointestinal bleeding or any other hemorrhage/bleeding event Common Terminology Criteria for adverse Events (CTCAE), v. 4 grade 3 or greater within 30 days prior to registration
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration (with the exception of craniotomy)

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

National Cancer Institute

Christina TsienPrincipal Investigator

Jeffrey J. RaizerStudy Chair

Adam P. Dicker, MD, PhDStudy Chair

Martha M. Matuszak, PhDStudy Chair

Trial Sites

U.S.A.
Alabama
  Birmingham
 UAB Comprehensive Cancer Center
 John Fiveash Ph: 205-934-0309
  Mobile
 University of South Alabama Mitchell Cancer Institute
 Suzanne M Russo Ph: 251-665-8000
  Email: pfrancisco@usouthal.edu
Arizona
  Scottsdale
 Arizona Oncology Services Foundation
 David G. Brachman Ph: 800-360-6371
  Tucson
 Arizona Cancer Center at University of Arizona Health Sciences Center
 Baldassarre Dino Stea Ph: 520-626-9008
California
  Dublin
 Epic Care-Dublin
 James H. Feusner Ph: 510-450-7600
  La Jolla
 Rebecca and John Moores UCSD Cancer Center
 Jona A Hattangadi-Gluth Ph: 858-822-5354
  Email: cancercto@ucsd.edu
  Walnut Creek
 John Muir/Mt. Diablo Comprehensive Cancer Center
 Daniel M. Chinn Ph: 925-674-2580
Florida
  Deerfield Beach
 University of Miami/Deerfield Beach
 Fazilat Ishkanian Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
  Jacksonville
 Baptist Cancer Institute - Jacksonville
 Douglas W. Johnson Ph: 904-202-7051
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 Fazilat Ishkanian Ph: 866-574-5124
  Email: Sylvester@emergingmed.com
Georgia
  Atlanta
 Winship Cancer Institute of Emory University
 Ian R Crocker Ph: 404-778-1868
Hawaii
  Honolulu
 Queen's Cancer Institute at Queen's Medical Center
 Paul A. DeMare Ph: 808-545-8548
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Samir Narayan Ph: 734-712-3456
Illinois
  Chicago
 Robert H. Lurie Comprehensive Cancer Center at Northwestern University
 Jeffrey J. Raizer Ph: 312-695-1301
  Email: cancer@northwestern.edu
 University of Chicago Cancer Research Center
 Steven J Chmura Ph: 773-834-7424
  Warrenville
 Central Dupage Cancer Center
 Vinai Gondi Ph: 630-352-5300
Indiana
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
 Radiation Oncology Associates Southwest
 Brian K Chang Ph: 260-373-8888
  Email: parkviewresearch@parkview.com
  Indianapolis
 Community Regional Cancer Care at Community Hospital East
 Shih J Wei Ph: 317-621-7104
 Community Regional Cancer Care at Community Hospital North
 Shih J Wei Ph: 317-621-7104
 Methodist Cancer Center at Methodist Hospital
 Peter A. Johnstone Ph: 317-274-2552
  South Bend
 Memorial Hospital of South Bend
 David A. Hornback Ph: 800-284-7370
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Parvesh Kumar Ph: 913-588-4709
  Overland Park
 Kansas City Cancer Centers - Southwest
 Parvesh Kumar Ph: 913-588-4709
Kentucky
  Lexington
 Central Baptist Hospital
 Marta S Hayne Ph: 859-260-6425
 University of Kentucky Chandler Medical Center
 John L Villano Ph: 859-257-3379
  Louisville
 Louisville Oncology at Norton Cancer Institute - Louisville
 Aaron C Spalding Ph: 502-629-2500
Maine
  Scarborough
 Maine Medical Center- Scarborough Campus
 Ian J Bristol Ph: 207-396-8090
  Email: wrighd@mmc.org
Massachusetts
  Boston
 Dana-Farber/Brigham and Women's Cancer Center
 Kevin S Oh Ph: 877-726-5130
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Kevin S Oh Ph: 877-726-5130
 Massachusetts General Hospital
 Kevin S Oh Ph: 877-726-5130
  Lowell
 Lowell General Hospital
 Matthew S Katz Ph: 978-788-7084
  Email: ghincks@lowellgeneral.org
Michigan
  Ann Arbor
 Saint Joseph Mercy Cancer Center
 Samir Narayan Ph: 734-712-3456
 University of Michigan Comprehensive Cancer Center
 Christina I. Tsien Ph: 800-865-1125
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Samir Narayan Ph: 734-712-3456
  Kalamazoo
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
  Warren
 St. John Macomb Hospital
 Samir Narayan Ph: 734-712-3456
Missouri
  Kansas City
 Kansas City Cancer Centers - North
 Parvesh Kumar Ph: 913-588-4709
 Kansas City Cancer Centers - South
 Parvesh Kumar Ph: 913-588-4709
  Lee's Summit
 Kansas City Cancer Centers - East
 Parvesh Kumar Ph: 913-588-4709
  Rolla
 Phelps County Regional Medical Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
  Saint Louis
 Barnes-Jewish West County Hospital
 Jiayi Huang Ph: 800-600-3606
  Email: info@siteman.wustl.edu
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Jiayi Huang Ph: 800-600-3606
  Email: info@siteman.wustl.edu
  Springfield
 St. John's Regional Health Center
 Jay W Carlson Ph: 800-821-7532
  Email: sherrijr@iora.org
Nebraska
  Omaha
 Methodist Estabrook Cancer Center
 Tien-Shew W Huang Ph: 402-354-5144
New Jersey
  Newark
 UMDNJ University Hospital
 Sabin B Motwani Ph: 732-235-8675
New York
  Bronx
 Montefiore Medical Center
 Mary R Welch Ph: 718-904-2730
  Email: aecc@aecom.yu.edu
  New Hyde Park
 Monter Cancer Center of the North Shore-LIJ Health System
 Jonathan P. S. Knisely Ph: 516-562-3467
  New York
 St. Luke's - Roosevelt Hospital Center - St.Luke's Division
 Rahul R Parikh Ph: 888-823-5923
  Email: ctsucontact@westat.com
  Rochester
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Carolina
  Greensboro
 Moses Cone Regional Cancer Center at Wesley Long Community Hospital
 Matthew A Manning Ph: 336-832-0821
  Winston-Salem
 Forsyth Regional Cancer Center at Forsyth Medical Center
 Volker W Stieber Ph: 336-277-8887
Ohio
  Akron
 Summa Center for Cancer Care at Akron City Hospital
 Charles A Kunos Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 Charles A Kunos Ph: 330-375-6101
  Cleveland
 Case Comprehensive Cancer Center
 Simon Shek-Man Lo Ph: 800-641-2422
  Columbus
 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
 Michael W Guiou Ph: 866-627-7616
  Email: osu@emergingmed.com
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence S. Herman Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Oregon
  Clackamas
 Clackamas Radiation Oncology Center
 Matthew C Solhjem Ph: 503-215-6412
  Portland
 Legacy Good Samaritan Hospital & Comprehensive Cancer Center
 Andrew Y Kee Ph: 507-538-7623
 Providence Cancer Center at Providence Portland Medical Center
 Matthew C Solhjem Ph: 503-215-6412
 Providence St. Vincent Medical Center
 Matthew C Solhjem Ph: 503-215-6412
Pennsylvania
  Hershey
 Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
 Henry Wagner Ph: 717-531-3779
  Email: CTO@hmc.psu.edu
  Lancaster
 Lancaster General Hospital
 Jeffery S Eshleman Ph: 717-544-5511
  Philadelphia
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Maria Werner-Wasik Ph: 215-955-6084
  West Reading
 McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
 Albert Yuen Ph: 610-988-9323
South Carolina
  Greer
 Gibbs Cancer Center-Pelham
 Patricia C Griffin Ph: 800-486-5941
  Spartanburg
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 Patricia C Griffin Ph: 800-486-5941
South Dakota
  Rapid City
 Rapid City Regional Hospital
 Michael J Swartz Ph: 605-716-3982
  Email: research@rcrh.org
Tennessee
  Knoxville
 Thompson Cancer Survival Center
 Daniel D Scaperoth Ph: 865-541-1812
Texas
  Galveston
 University of Texas Medical Branch
 Martin Colman Ph: 409-772-1950
  Email: clinical.research@utmb.edu
  League City
 UTMB Cancer Center at Victory Lakes
 Martin Colman Ph: 409-772-1950
  Email: clinical.research@utmb.edu
Washington
  Seattle
 University Cancer Center at University of Washington Medical Center
 George E. Laramore Ph: 206-616-8289
  Yakima
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
Wisconsin
  Green Bay
 St. Mary's Hospital Medical Center - Green Bay
 Gregory M. Cooley Ph: 920-433-8889
 St. Vincent Hospital Regional Cancer Center
 Gregory M. Cooley Ph: 920-433-8889
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Gregory M. Cooley Ph: 920-433-8889
  Mukwonago
 D.N. Greenwald Center
 Wingate F. Clapper Ph: 262-928-7632
  Oconomowoc
 Regional Cancer Center at Oconomowoc Memorial Hospital
 Wingate F. Clapper Ph: 262-928-7632
  Sturgeon Bay
 Door County Cancer Center at Door County Memorial Hospital
 Gregory M. Cooley Ph: 920-433-8889
  Waukesha
 Waukesha Memorial Hospital Regional Cancer Center
 Wingate F. Clapper Ph: 262-928-7632
Canada
Saskatchewan
  Regina
 Allan Blair Cancer Centre at Pasqua Hospital
 Rashmi Koul Ph: 866-561-1026
  Email: CIO_Web@cancercare.mb.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01730950
ClinicalTrials.gov processed this data on May 19, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

Back to TopBack to Top