Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:June 4, 2012

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Phase II Double-Blinded Placebo-Controlled Study of Bevacizumab With or Without AMG 386 in Patients With Recurrent Glioblastoma or Gliosarcoma

This partially randomized phase II trial with a safety run-in component studies the side
effects and how well bevacizumab given with or without trebananib works in treating patients
with brain tumors that have come back (recurrent). Immunotherapy with monoclonal antibodies,
such as bevacizumab, may induce changes in the body's immune system and interfere with the
ability of tumor cells to grow and spread. Trebananib may stop the growth of tumor cells by
blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together
with trebananib is more effective than bevacizumab alone in treating brain tumors.

PRIMARY OBJECTIVES:

I. To assess the safety and tolerability of AMG 386 (trebananib) 15 mg/kg weekly in
combination with bevacizumab 10 mg/kg every 2 weeks (Cohort 1). (closed to accrual 10/2/12)
II. To assess the efficacy of AMG 386 in combination with bevacizumab 10 mg/kg every 2 weeks
compared to bevacizumab monotherapy in bevacizumab-naive patients, as measured by 6-month
progression-free survival (PFS6) (Cohort 2).

SECONDARY OBJECTIVES:

I. To further assess the toxicity profile (Cohorts 1 and 2). II. To assess feasibility of AMG
386 15 mg/kg weekly in combination with bevacizumab 10 mg/kg every 2 weeks (Cohort 1 [closed
to accrual 10/2/12]), as measured by the percentage of patients requiring dose
reduction/interruption or discontinuation in the first 2 and subsequent cycles.

III. To determine the radiographic response rate (RR), median progression-free survival
(PFS), and overall survival (OS) in bevacizumab-naive patients (Cohort 2).

IV. To assess the efficacy of AMG 386 15 mg/kg weekly in combination with bevacizumab 10
mg/kg every 2 weeks in patients who have progressed while on bevacizumab, as measured by
overall survival (OS) (cross-over from placebo arm of Cohort 2).

V. To correlate outcome to treatment with tumor genotype, expression profile, and circulating
angiogenesis biomarkers in tumor specimens (Cohort 2).

VI. To determine the RR, PFS6, and PFS in patients who have progressed while on bevacizumab
therapy and receive AMG 386 in combination with bevacizumab (cross-over from placebo arm of
Cohort 2).

VII. To determine the serum pharmacokinetics of AMG 386 in patients receiving bevacizumab
(Cohort 1 and cross-over from placebo arm of Cohort 2).

OUTLINE: This is a safety study (cohort 1 [closed to accrual 10/2/12]) followed by a
randomized study (cohort 2).

Cohort 1: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15
and trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity. (closed to accrual 10/2/12)

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

ARM I: Patients receive bevacizumab and trebananib as in Cohort 1.

ARM II: Patients receive bevacizumab as in Arm I and placebo IV over 30-60 minutes on days 1,
8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity. Patients with disease progression may cross over to Arm I.

After completion of study treatment, patients are followed up at 30 days, every 2 months for
1 year, every 6 months for 1 year, and then annually thereafter.

Inclusion Criteria:

- Histologically proven diagnosis of glioblastoma or variants (gliosarcoma, glioblastoma
with oligodendroglial features, giant cell glioblastoma); patients will be eligible if
the original histology was a lower grade glioma and a subsequent histological
diagnosis of glioblastoma or variants is made

- The tumor must be supratentorial; patients with infratentorial disease, spinal cord
disease, and/or leptomeningeal disease are excluded

- Patients must have shown unequivocal evidence for tumor progression on the previous
treatment regimen (prior to enrollment on this study) by magnetic resonance imaging
(MRI) scan of the brain with and without contrast within 14 days prior to
registration; the dose of steroids must be stable or decreasing for at least 5 days
prior to the scan; patients with tumor progression who then undergo surgical resection
prior to enrollment on study may be eligible as long as pathology confirms progressive
or recurrent glioblastoma multiforme (GBM) (or variants); for patients who undergo
surgical resection, registration on study may not occur any sooner than 28 days from
surgery; an MRI scan of the brain with and without contrast is still required within
14 days prior to registration on study but is not required to demonstrate measurable
disease or tumor progression after surgery

- Patients unable to undergo MRI because of non-compatible devices can be enrolled,
provided computed tomography (CT) scans are obtained and are of sufficient quality;
patients without non-compatible devices may not have CT scans performed to meet this
requirement

- History/physical examination within 14 days prior to registration

- Karnofsky performance scale >= 70 within 14 days prior to registration

- Patients who have received prior treatment with interstitial brachytherapy,
stereotactic radiosurgery, or implanted chemotherapy sources, such as wafers of
polifeprosan 20 with carmustine, must have confirmation of progressive disease within
14 days prior to registration based upon nuclear imaging, magnetic resonance (MR)
spectroscopy, perfusion imaging, or histopathology

- Leukocytes > 3,000/mm^3 (within 14 days prior to registration)

- Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to
registration)

- Hemoglobin >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= 10.0 g/dL is acceptable) (within 14 days prior to registration)

- Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 2.5 X institutional upper limit of normal (within 14 days prior to registration)

- Bilirubin =< 2.0 mg/dL (within 14 days prior to registration)

- Creatinine within normal upper institutional limits or creatinine clearance > 60
mL/min/1.73 m^2 (per 24 hour urine collection or calculated according to the
Cockcroft-Gault formula) for subjects with creatinine levels above the institutional
normal (within 14 days prior to registration)

- Patients with creatinine levels below normal institutional limits are eligible

- Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 (within 14 days
prior to registration)

- Urinary protein =< 30 mg/dL in urinalysis or =< 1+ on dipstick (within 14 days prior
to registration)

- Generally well-controlled blood pressure with systolic blood pressure =< 140 mm Hg AND
diastolic blood pressure =< 90 mm Hg within 5 days prior to registration; the use of
anti-hypertensive medications to control hypertension is permitted

- Women of childbearing potential must have a negative serum beta-human chorionic
gonadotropin (HCG) pregnancy test within 14 days prior to registration

- Women of childbearing potential and male patients who are sexually active must
practice adequate contraception during therapy and for 180 days (6 months) afterwards

- Patient must provide study specific informed consent prior to study entry

Exclusion Criteria:

- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity,
or cervix are all permissible)

- Prior systemic cytotoxic chemotherapy within (i.e., =<) 28 days (42 days for
nitrosoureas or mitomycin C) prior to registration, or patients who have not returned
to baseline or =< Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v.
4) grade 2 from adverse events (excluding alopecia) due to agents administered more
than 28 days prior to registration

- Patients who received non-cytotoxic drug therapy must be off treatment for at least 14
days prior to registration; prior treatment with anti-vascular endothelial growth
factor (VEGF) targeted agents; AMG 386 therapy; or other molecules that inhibit
angiopoietins or TEK tyrosine kinase, endothelial (Tie2) receptor including, but not
limited to, XL-820, XL-184 (cabozantinib-s-malate), and CVX-060/PF-4856884 is not
allowed regardless of time frame

- Patients who have not yet completed at least 21 days (30 days for prior monoclonal
antibody therapy) since ending other investigational device or drug trials, or who are
currently receiving other investigational treatments

- Treatment within 30 days prior to enrollment with strong immune modulators, including
but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate
mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide, and
targeted immune modulators such as abatacept (CTLA-4-Ig), adalimumab, alefacept,
anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab

- Prior radiotherapy within 90 days (3 months) prior to registration unless there is
either: a) histopathologic confirmation of recurrent tumor; or b) new enhancement on
MRI outside of the radiation treatment field

- Major surgical procedure (including craniotomy and open brain biopsy) or significant
traumatic injury within 28 days prior to registration or those patients who receive a
non-central nervous system (CNS) minor surgical procedures (e.g. core biopsy or fine
needle aspiration) within 3 days prior to registration; there is no waiting period for
central line placement; there is a 7-day window for recovery prior to registration for
patients who underwent stereotactic biopsy of the brain

- Prior therapy with anti-VEGF targeted agents (e.g. bevacizumab, cediranib, vandetanib,
aflibercept, sunitinib, sorafenib, etc.); prior therapy with thalidomide and
lenalidomide is allowed as long as treatment has not occurred within 30 days prior to
enrollment

- More than 2 relapses

- Therapeutic anticoagulation with warfarin < 7 days prior to registration; (therapeutic
or prophylactic therapy with aspirin, a low-molecular weight heparin, or a Factor Xa
inhibitor is acceptable)

- Intratumoral hemorrhage or peritumoral hemorrhage, demonstrated by MRI or CT scan,
CTCAE, v. 4 grade 2 or greater or evidence of significant hemorrhage (regardless of
CTCAE, v. 4 grade) defined as > 1 cm diameter of blood (including postoperative
hemorrhage)

- Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE, v. 4 grade 3
or greater within 30 days prior to study entry

- Severe, active co-morbidity, defined as follows:

- Unstable angina and/or congestive heart failure requiring hospitalization within
180 days (6 months) prior to registration

- Transmural myocardial infarction within 180 days (6 months) prior to registration

- History of stroke, cerebral vascular accident (CVA), or transient ischemic attack
within 180 days (6 months) prior to registration

- 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

- 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

- Known coagulopathy that increases risk of bleeding or a history of clinically
significant hemorrhages in the past

- History of non-healing wounds or ulcers, or bone fractures within 90 days (3
months) prior to registration

- History of venous or arterial thromboembolism within 12 months prior to
registration

- Prior allergic reaction to the study drugs involved in this study
We found this trial at
245
sites
8th Ave & C St
Salt Lake City, Utah 84143
(801) 408-1100
LDS Hospital LDS Hospital provides clinical excellence to our community in a wide range of...
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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601 South Sherman Street
Spokane, Washington 99202
(509) 228-1000
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1 Akron General Avenue
Akron, Ohio 44307
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170 North 1100 East
American Fork, Utah 84003
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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Ann Arbor, Michigan 48106
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Antigo, Wisconsin 54409
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Asheville, North Carolina 28801
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Asheville, North Carolina 28801
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Asheville, North Carolina 28801
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Asheville, North Carolina 28803
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Austin, Texas 78705
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155 5th St NE
Barberton, Ohio 44203
(330) 615-3000
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Beaver, Pennsylvania 15009
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Bedford, Texas 76022
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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130 S Bryn Mawr Ave
Bryn Mawr, Pennsylvania 19010
(484) 337-3000
Bryn Mawr Hospital Bryn Mawr Hospital, a nationally recognized community teaching hospital, is conveniently located...
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1501 Trousdale Drive
Burlingame, California 94010
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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Cape Girardeau, Missouri 63703
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1303 North Main Street
Cedar City, Utah 84721
(435) 868-5680
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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3100 Plaza Properties Blvd
Columbus, Ohio 43219
(614) 383-6000
The Mark H. Zangmeister Center At The Zangmeister Center, we appreciate that our patients have...
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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810 Jasonway Avenue
Columbus, Ohio 43214
614/442-3130
Columbus Oncology and Hematology Associates Inc Columbus Oncology and Hematology Associates is a group of...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Columbus, Ohio 43222
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
(763) 236-6000
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Danville, Illinois 61832
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Dearborn, Michigan 48124
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Decatur, Illinois 62526
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Delaware, Ohio 43015
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
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561 West Central Avenue
Delaware, Ohio 43015
(740) 615-1000
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Detroit, Michigan 48236
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6401 France Ave S
Edina, Minnesota 55435
(952) 924-5000
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Effingham, Illinois 62401
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3401 Ludington St
Escanaba, Michigan 49829
(800) 432-6049
Green Bay Oncology - Escanaba We are one of a select few physician groups in...
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Eugene, Oregon 97401
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Farrell, Pennsylvania 16121
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1255 Hwy 54 W,
Fayetteville, Georgia 30214
(770) 719-7000
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
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Fort Worth, Texas 76104
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Unity Hospital Unity Hospital is one of the Twin Cities
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743 Spring Street Northeast
Gainesville, Georgia 30501
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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40 V-Twin Drive
Gettysburg, Pennsylvania 17325
(717) 339-2640
Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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Grapevine, Texas 76051
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1726 Shawano Ave.
Green Bay, Wisconsin 54303
(920) 884-3135
Green Bay Oncology Limited at Saint Mary's Hospital We are one of a select few...
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835 S. Van Buren St.
Green Bay, Wisconsin 54301
(920) 884-3135
Green Bay Oncology at Saint Vincent Hospital We are one of a select few physician...
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835 S Van Buren St
Green Bay, Wisconsin 54301
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1726 Shawano Avenue
Green Bay, Wisconsin 54303
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Greensburg, Pennsylvania 15601
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Greer, South Carolina 29651
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773 Cherry Tree Ct
Hanover, Pennsylvania 17331
(717) 633-9573
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Hendersonville, North Carolina 28792
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
Hutchinson Area Health Care Hutchinson Health is a team of medical professionals and support staff...
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Independence, Missouri 64057
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1721 S Stephenson Ave
Iron Mountain, Michigan 49801
(906) 776-5660
Green Bay Oncology - Iron Mountain We are one of a select few physician groups...
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Joplin, Missouri 64804
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
Borgess Medical Center At Borgess, healing is our calling. This is the place where people...
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Kalamazoo, MI
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