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



Status:Recruiting
Conditions:Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2012

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Randomized Phase II Trial of Concurrent Bevacizumab and Re-irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

This randomized phase II trial studies how well bevacizumab with or without radiation
therapy works in treating patients with glioblastoma that has returned after a period of
improvement. Monoclonal antibodies, such as bevacizumab, may block tumor growth by targeting
certain cells. 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
known whether bevacizumab is more effective with or without radiation therapy in treating
patients with recurrent glioblastoma.

PRIMARY OBJECTIVES:

I. To establish an improvement in overall survival in recurrent glioblastoma multiforme
(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 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 with bevacizumab 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.

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 MRI
scan (or CT scan for patients with non-compatible devices) within 21 days prior
to registration; Note: patients who did have surgery with a post-operative
contrast-enhanced scan falling outside the 5-week window prior to registration,
per definition of recent surgery, must have a repeat magnetic resonance imaging
(MRI) scan (or computed tomography [CT] scan for patients with non-compatible
devices) within 21 days prior to registration

- Patients 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 as long as the criterion is met or approved by a
principal investigator

- 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 or intra-operative MRI scan (or CT scan for
patients with non-compatible devices) must be performed 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 positive (+) (patients discovered to have > 2+
proteinuria on dipstick urinalysis at baseline must have a UPC ratio done that is <
1.0 to be eligible; if the UPC ratio is >= 1.0 then the patients 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

- Patients must not be pregnant (positive pregnancy test) or breast feeding; pregnancy
test must be done within 7 days prior to registration; effective contraception (men
and women) must be used in patients of child-bearing potential while on study
treatment and for 6 months after

- Patients on full-dose anticoagulants (e.g., warfarin or low molecular weight [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, within 14 days prior to registration

- 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 VEGF
receptor (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

- 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)
We found this trial at
193
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1015 NW 22nd Ave
Portland, Oregon 97210
(503) 413-7711
Principal Investigator: Andrew Y. Kee
Phone: 800-220-4937
Legacy Good Samaritan Hospital and Medical Center Located in the heart of Northwest Portland, Legacy...
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: John E. Mignano
Phone: 617-636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Principal Investigator: Samir P. Kanani
Phone: 703-208-6650
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
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University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Mark D. Anderson
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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185 S Orange Ave
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UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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4805 Northeast Glisan Street
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401 College Street
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Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
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(585) 275-2121
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808 North 39th Avenue
Yakima, Washington 98902
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Akron, Ohio 44304
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1 Akron General Ave
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1500 East Medical Center Drive
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Annapolis, Maryland 21401
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550 Peachtree St NE
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Atlanta, Georgia 30322
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1968 Peachtree Rd NW
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1000 Johnson Ferry Rd NE
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Austin, Texas 78701
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
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Bay Shore, New York 11706
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Beaver, Pennsylvania 15009
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Bel Air, Maryland 21014
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1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
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Phone: 701-234-6161
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
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Berlin, Vermont 05602
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Bethlehem, Pennsylvania 18015
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
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Birmingham, Alabama 35233
Principal Investigator: John B. Fiveash
Phone: 205-934-0309
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300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
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Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
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Boise, Idaho 83706
Principal Investigator: Samir Narayan
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Kevin S. Oh
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
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Bridgeport, Connecticut 06606
Principal Investigator: Nicholas A. Blondin
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Bronx, New York 10467
Principal Investigator: Mary R. Welch
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Burbank, California
Principal Investigator: Matthew C. Solhjem
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Burlington, Massachusetts 01805
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Burlington, Vermont 05405
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Cameron Park, California 95682
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Cape Girardeau, Missouri 63703
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Scott M. Lindhorst
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Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Ashley L. Sumrall
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jeffrey J. Raizer
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Thomas E. Lad
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John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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1200 West Harrison Stree
Chicago, Illinois 60607
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Univ of Illinois A major research university in the heart of one of the world's...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Steven J. Chmura
Phone: 773-834-7424
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
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Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Simon S. Lo
Phone: 800-641-2422
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
(719) 776-5000
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Colorado Springs, Colorado 80903
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
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Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Cumming, Georgia 30041
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
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Deerfield Beach, Florida 33442
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Samir Narayan
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Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Dublin, California 94568
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820 4th St N
Fargo, North Dakota 58102
(701) 234-6161
Principal Investigator: Preston D. Steen
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Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fort Wayne, Indiana 46804
Principal Investigator: Brian K. Chang
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2200 Randallia Drive
Fort Wayne, Indiana 46805
Principal Investigator: Brian K. Chang
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Fresno, California 93720
Principal Investigator: Samantha A. Seaward
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Gastonia, North Carolina 28054
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Phone: 920-433-8889
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1726 Shawano Ave
Green Bay, Wisconsin 54303
(920) 498-4200
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Saint Mary's Hospital Our team of dedicated physicians, nurses and staff offer a broad spectrum...
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501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Principal Investigator: Matthew A. Manning
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Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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Greensburg, Pennsylvania 15601
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Greenville, South Carolina 29605
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Greenville, South Carolina 29615
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Greer, South Carolina 29650
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Greer, South Carolina 29651
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Henderson, Nevada 89052
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Principal Investigator: Henry Wagner
Phone: 717-531-3779
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Paul A. DeMare
Phone: 808-545-8548
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Indianapolis, Indiana 46202
Principal Investigator: Mark P. Langer
Phone: 317-274-2552
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Indianapolis, Indiana 46219
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Indianapolis, Indiana 46256
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Jacksonville, Florida
Principal Investigator: Mark E. Augspurger
Phone: 904-202-7051
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Joliet, Illinois 60435
Principal Investigator: Kulumani M. Sivarajan
Phone: 815-730-3098
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Kansas City, Kansas 66160
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Kansas City, Missouri 64131
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4401 Wornall Rd
Kansas City, Missouri 64111
(816) 932-2000
Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Principal Investigator: Rakesh Gaur
Phone: 816-932-2677
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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8700 N. Green Hills Road
Kansas City, Missouri 64154
816.746.4570
Kansas City Cancer Centers - North Through world-class research and patient care, The University of...
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Kennewick, Washington 99336
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Kennewick, Washington 99336
Principal Investigator: George E. Laramore
Phone: 206-616-8289
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Knoxville, Tennessee 37920
Principal Investigator: Marcio A. Fagundes
Phone: 865-244-3209
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Principal Investigator: Daniel D. Scaperoth
Phone: 865-541-1812
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
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La Crosse, Wisconsin
Principal Investigator: Collin D. Driscoll
Phone: 608-775-2385
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Las Vegas, Nevada 89128
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Las Vegas, Nevada 89144
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Las Vegas, Nevada 89169
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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