Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01730950 : Bevacizumab With or Without Radiation Therapy in Treating Patients With Recurrent Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
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.

* Note: Patients who did have surgery with a post-operative contrast-enhance scan
falling outside the 5 week window prior to registration, must have a repeat MRI scan
(or CT scan for patients with non-compatible devices) 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 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+ (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, 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 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)
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01730950      |      Link to official Clinicaltrials.gov listing
Locations
Birmingham, Alabama
Facility: University of Alabama at Birmingham
Investigator: John B. Fiveash
Contact: John B. Fiveash Phone: 205-934-0309
Email not avaialable

Phoenix, Arizona
Facility: Arizona Oncology Services Foundation
Investigator: David G. Brachman
Contact: David G. Brachman Phone: 800-360-6371
Email not avaialable

Phoenix, Arizona
Facility: Arizona Oncology-Deer Valley Center
Investigator: David G. Brachman
Contact: David G. Brachman Phone: 800-360-6371
Email not avaialable

Walnut Creek, California
Facility: John Muir Medical Center
Investigator: Daniel M. Chinn
Contact: Daniel M. Chinn Phone: 925-674-2580
Email not avaialable

New Haven, Connecticut
Facility: Yale University
Investigator: Joseph N. Contessa
Contact: Joseph N. Contessa Phone: 203-785-5702
Email not avaialable

Miami, Florida
Facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
Investigator: Fazilat Ishkanian
Contact: Fazilat Ishkanian Phone: 866-574-5124
Click HERE to send email to this center

Honolulu, Hawaii
Facility: Queen's Medical Center
Investigator: Paul A. DeMare
Contact: Paul A. DeMare Phone: 808-545-8548
Email not avaialable

Fort Wayne, Indiana
Facility: Radiation Oncology Associates PC
Investigator: Brian K. Chang
Contact: Brian K. Chang Phone: 260-373-8888
Click HERE to send email to this center

Indianapolis, Indiana
Facility: IU Health Methodist Hospital
Investigator: Peter A. Johnstone
Contact: Peter A. Johnstone Phone: 317-274-2552
Email not avaialable

South Bend, Indiana
Facility: Memorial Hospital of South Bend
Investigator: David A. Hornback
Contact: David A. Hornback Phone: 800-284-7370
Email not avaialable

Louisville, Kentucky
Facility: Norton Health Care Pavilion - Downtown
Investigator: Aaron C. Spalding
Contact: Aaron C. Spalding Phone: 502-629-2500
Email not avaialable

Scarborough, Maine
Facility: Maine Medical Center- Scarborough Campus
Investigator: Ian J. Bristol
Contact: Ian J. Bristol Phone: 207-396-8090
Click HERE to send email to this center

Lowell, Massachusetts
Facility: Lowell General Hospital
Investigator: Matthew S. Katz
Contact: Matthew S. Katz Phone: 978-788-7084
Click HERE to send email to this center

Ann Arbor, Michigan
Facility: University of Michigan University Hospital
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 800-865-1125
Email not avaialable

Kalamazoo, Michigan
Facility: West Michigan Cancer Center
Investigator: Raymond S. Lord
Contact: Raymond S. Lord Phone: 269-373-7458
Email not avaialable

Saint Louis, Missouri
Facility: Washington University School of Medicine
Investigator: Jiayi Huang
Contact: Jiayi Huang Phone: 800-600-3606
Click HERE to send email to this center

Omaha, Nebraska
Facility: Nebraska Methodist Hospital
Investigator: Tien-Shew W. Huang
Contact: Tien-Shew W. Huang Phone: 402-354-5144
Email not avaialable

Rochester, New York
Facility: University of Rochester
Investigator: Yuhchyau Chen
Contact: Yuhchyau Chen Phone: 585-275-5830
Email not avaialable

Greensboro, North Carolina
Facility: Cone Health Cancer Center
Investigator: Matthew A. Manning
Contact: Matthew A. Manning Phone: 336-832-0821
Email not avaialable

Akron, Ohio
Facility: Summa Akron City Hospital
Investigator: Charles A. Kunos
Contact: Charles A. Kunos Phone: 800-641-2422
Email not avaialable

Barberton, Ohio
Facility: Summa Barberton Hospital
Investigator: Charles A. Kunos
Contact: Charles A. Kunos Phone: 800-641-2422
Email not avaialable

Lancaster, Pennsylvania
Facility: Lancaster General Hospital
Investigator: Jeffery S. Eshleman
Contact: Jeffery S. Eshleman Phone: 717-544-5511
Email not avaialable

Philadelphia, Pennsylvania
Facility: Radiation Therapy Oncology Group
Investigator: Christina I. Tsien
Contact: Christina I. Tsien Phone: 734-936-4307
Click HERE to send email to this center

Pittsburgh, Pennsylvania
Facility: Allegheny Cancer Center at Allegheny General Hospital
Investigator: Stephen M. Karlovits
Contact: Stephen M. Karlovits Phone: 877-284-2000
Email not avaialable

Charleston, South Carolina
Facility: Medical University of South Carolina
Investigator: Pierre Giglio
Contact: Pierre Giglio Phone: 843-792-9321
Email not avaialable

Galveston, Texas
Facility: University of Texas Medical Branch
Investigator: Martin Colman
Contact: Martin Colman Phone: 409-772-1950
Click HERE to send email to this center

Yakima, Washington
Facility: North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Investigator: Sean F. Cleary
Contact: Sean F. Cleary Phone: 877-902-3324
Email not avaialable

Green Bay, Wisconsin
Facility: Saint Vincent Hospital
Investigator: Gregory M. Cooley
Contact: Gregory M. Cooley Phone: 920-433-8889
Email not avaialable

Green Bay, Wisconsin
Facility: Saint Mary's Hospital
Investigator: Gregory M. Cooley
Contact: Gregory M. Cooley Phone: 920-433-8889
Email not avaialable

Marinette, Wisconsin
Facility: Bay Area Medical Center
Investigator: Gregory M. Cooley
Contact: Gregory M. Cooley Phone: 920-433-8889
Email not avaialable

Sturgeon Bay, Wisconsin
Facility: Door County Cancer Center
Investigator: Gregory M. Cooley
Contact: Gregory M. Cooley Phone: 920-433-8889
Email not avaialable




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