Vorinostat, Temozolomide, or Bevacizumab in Combination With Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients With Newly Diagnosed High-Grade Glioma



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 21
Updated:1/27/2019
Start Date:November 15, 2010
End Date:September 27, 2016

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A Randomized Phase II/III Study of Vorinostat and Local Irradiation OR Temozolomide and Local Irradiation OR Bevacizumab and Local Irradiation Followed by Maintenance Bevacizumab and Temozolomide in Children With Newly Diagnosed High-Grade Gliomas

This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to
see how well they work compared with each other when given together with radiation therapy
followed by bevacizumab and temozolomide in treating young patients with newly diagnosed
high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. 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 tumor-killing substances to them. Radiation therapy uses
high-energy x-rays to kill tumor cells. It is not yet known whether giving vorinostat is more
effective then temozolomide or bevacizumab when given together with radiation therapy in
treating glioma.

PRIMARY OBJECTIVES:

I. To identify the dose of vorinostat that is feasible when given in combination with
radiotherapy (RT) in patients with newly diagnosed high-grade gliomas (HGG). II. To compare
1-year event-free survival of patients with newly diagnosed HGG treated with vorinostat
(using MTD) versus bevacizumab versus temozolomide when given in combination with RT followed
by maintenance therapy with bevacizumab and temozolomide. (Phase II) III. To compare the
event-free survival of patients with newly diagnosed HGG treated with the superior
chemoradiotherapy (from phase II portion) versus temozolomide given in combination with RT
followed by maintenance chemotherapy with bevacizumab and temozolomide. (Phase III)

SECONDARY OBJECTIVES:

I. To evaluate the anti-tumor activity, as measured by event-free survival (EFS),
progression-free survival (PFS), and overall survival (OS), of patients with newly diagnosed
HGG treated with vorinostat, bevacizumab, or temozolomide when given in combination with RT
followed by maintenance chemotherapy with bevacizumab and temozolomide. II. To define and
evaluate the toxicities of each of the treatment arms of the study.

III. To conduct gene expression profiling and SNP arrays in patients with newly diagnosed
HGG.

IV. To assess telomerase activity, hTert expression, and telomere length in patients with
newly diagnosed HGG. V. To document changes in perfusion and diffusion using MR imaging at
baseline, prior to, during (prior to course 3), and after maintenance therapy with
bevacizumab and temozolomide.

VI. To correlate functional changes in tumor with responses to bevacizumab treatment using MR
diffusion/perfusion imaging. VII. To correlate the results of the bevacizumab biology studies
in serum or tumor with EFS.

VIII. To explore the prognostic significance of MGMT status for patients newly diagnosed with
HGG treated with combined surgery, radiation, chemotherapy, and anti-angiogenic therapy.

OUTLINE: This is a multicenter, feasibility, dose-escalation study of vorinostat, followed by
a phase II study, followed by a phase III study.

FEASIBILITY STUDY: Patients undergo 3-D conformal radiotherapy (RT) or intensity-modulated RT
5 days a week for 6 weeks. Patients also receive vorinostat orally (PO) once daily on days
1-5. Courses repeat every week for 6 weeks in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 4 weeks after completion of chemoradiotherapy, patients
receive bevacizumab IV over 30-90 minutes on days 1 and 15 and temozolomide PO on days 1-5.
Treatment repeats every 28 days for 12 courses in the absence of disease progression or
unacceptable toxicity.

PHASE II STUDY: Patients are stratified according to extent of resection (near total
resection or gross total resection vs other) and histology (glioblastoma multiforme vs
other). Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients undergo RT 5 days a week for 6 weeks and receive vorinostat at the
maximum-tolerated dose determined in the feasibility study.

ARM II: Patients undergo RT as in arm I and receive temozolomide PO once daily for 42 days
beginning on day 5 of RT.

ARM III: Patients undergo RT as in arm I and receive bevacizumab IV over 30-90 minutes on
days 22 and 36. Patients in all arms receive maintenance therapy as in the feasibility study.

PHASE III study: Patients are randomized to 1 of 2 treatment arms.

ARM IV: Patients receive RT and temozolomide as in phase II, arm II.

ARM V: Patients receive treatment as in phase II, arm I or phase II, arm III, whichever was
established as the superior chemoradiotherapy arm in phase II. Patients in all arms receive
maintenance therapy as in the feasibility study. Some patients undergo blood and tumor tissue
sample (from surgery) collection for telomerase activity, hTert expression, telomere length,
and gene expression profiling and SNP arrays analysis.

After completion of study therapy, patients are followed up every 3 months for 1 year, every
6 months for 4 years, and then annually for 5 years.

Inclusion Criteria:

- Newly diagnosed high-grade glioma

- Anaplastic astrocytoma

- Glioblastomamultiforme

- Gliosarcoma

- Primary spinal cord malignant glioma allowed

- No oligodendroglioma oroligoastrocytoma

- Patient must have histological verification of diagnosis

- No M+ disease (defined as evidence of neuraxis dissemination)

- No positive CSF cytology

- ECOG performance status (PS) 0-2

- Karnofsky PS 50-100% (patients > 16 years of age)

- Lansky PS 50-100% (patients ? 16 years of age)

- ANC ? 1,000/?L

- Platelet count ? 100,000/?L

- Hemoglobin ? 8.0 mg/dL (transfusion independent)

- Creatinine clearance or radioisotope GFR ? 70 mL/min OR serum creatinine based on age
and/or gender as follows:

- 0.4 mg/dL (1 month to < 6 months of age)

- 0.5 mg/dL (6 months to < 1 year of age)

- 0.6 mg/dL (1 to < 2 years of age)

- 0.8 mg/dL (2 to < 6 years of age)

- 1.0 mg/dL (6 to < 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) or 1.4 mg/dL (female) (? 16 years of age)

- Proteinuria < 2+ OR urine; protein ratio (UPC) ? 0.5

- If UPC > 0.5, a 24-hour urine protein should be obtained and level should be <
1,000 mg of protein

- Total bilirubin ? 1.5 times upper limit of normal (ULN)

- ALT < 2.5 times ULN

- Serum albumin ? 2 g/dL

- PT INR ? 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during all study therapy and for ? 6
months after completion of bevacizumab

- Hypertension well controlled (? 95^th percentile for age and height if patient is ?
17years) by stable doses of medication allowed

- For patients > 17 years, systolic blood pressure (BP) ? 150 mm Hg or diastolic BP
? 100 mm Hg)

- Seizure disorder allowed provided patient is well-controlled and on nonenzyme-inducing
anticonvulsants

- No history of myocardial infarction, severe or unstable angina, clinically significant
peripheral vascular disease, ? grade 2 heart failure, or serious and inadequately
controlled cardiac arrhythmia

- No known bleeding diathesis or coagulopathy

- No prior arterial thromboembolic events, including transient ischemic attacks
orcerebrovascular accidents

- No prior diagnosis of a deep venous thrombosis, including pulmonary embolism, and no
known thrombophilic condition (e.g., protein S, protein C, antithrombin III
deficiency, Factor V Leiden or Factor II G202`0A mutation, homocysteinemia, or
antiphospholipid antibody syndrome)

- No history of an abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the past 6 months

- No serious or non-healing wound, ulcer, or bone fracture

- No evidence of significant postoperative intracranial hemorrhage, defined as > 1 cm of
blood on postoperative MRI scan (potentially in addition to the postoperative scan)
obtained within the past 14days

- No history of allergic reaction to Chinese hamster ovary cell products or other
recombinanthuman antibodies

- No more than 31 days since definitive surgery

- Must not have received any prior chemotherapy, radiotherapy, immunotherapy, or bone
marrow transplant

- More than 7 days since major surgical procedure and recovered

- For patients scheduled to receive bevacizumab:

- More than 28 days since major procedure

- More than 14 days since intermediate procedure

- More than 7 days since minor procedure (lumbar picture or placement of PICC
lines are not considered minor procedures)

- No other current anti-cancer agents

- No concurrent nonsteroidal anti-inflammatory medications known to inhibit platelet
function or known to selectively inhibit cyclooxygenase activity

- No concurrent enzyme inducing anticonvulsants

- No concurrent HDAC inhibitors (e.g., valproic acid)

- No concurrent anticoagulants including systemic thrombolytic agents, heparin, low
molecular weight heparins, or warfarin except as required to maintain patency of
pre-existing permanent vascular catheters or for prevention of thrombosis in the
post-operative period
We found this trial at
130
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
(484) 884-2200
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
(361) 694-5000
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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1200 Pleasant Street
Des Moines, Iowa 50309
(515) 241-KIDS
Blank Children's Hospital Blank Children's Hospital is completely dedicated to meeting the unique health care...
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9981 S Healthpark Dr # 465
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239-343-5000
Lee Memorial Health System Our origins can be traced to the Fall of 1916 when...
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3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
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Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
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2500 N State St
Jackson, Mississippi 39216
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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2401 Gillham Rd
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Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
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Oakland, California 94609
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Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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1717 South Orange Avenue # 100
Orlando, Florida 32806
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Nemours Children's Clinic - Orlando Located near downtown Orlando, Nemours Children’s Clinic, Orlando is a...
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5153 North 9th Avenue
Pensacola, Florida 32504
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Nemours Children's Clinic - Pensacola Nemours Children’s Clinic, Pensacola serves children and families in northwest...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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620 John Paul Jones Cir
Portsmouth, Virginia 23708
(757) 953-5008
Naval Medical Center - Portsmouth Naval Medical Center Portsmouth, Virginia has proudly served the military...
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593 Eddy Street
Providence, Rhode Island 02903
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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7700 Floyd Curl Dr
San Antonio, Texas 78229
(210) 575-7000
Methodist Children's Hospital of South Texas Methodist Children
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Albany, New York 12208
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
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450 Brookline Ave
Boston, Massachusetts 2215
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
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Charlotte, North Carolina 28204
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
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1200 West Harrison Stree
Chicago, Illinois 60607
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Chicago, Illinois 60614
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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Dayton, Ohio 45404
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4160 John R St #2122
Detroit, Michigan 48201
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9333 Imperial Highway
Downey, California 90242
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East Lansing, Michigan 48824
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801 Broadway North
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801 7th Avenue
Fort Worth, Texas 76104
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900 West Faris Rd.
Greenville, South Carolina 29605
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BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
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30 Prospect Ave
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Hershey, Pennsylvania 17033
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Honolulu, Hawaii 96813
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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2018 W Clinch Ave
Knoxville, Tennessee 37916
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
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11234 Anderson St
Loma Linda, California 92354
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Madera, California 93638
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600 Highland Ave
Madison, Wisconsin 53792
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
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2525 Chicago Ave
Minneapolis, Minnesota 55404
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Nashville, Tennessee 37232
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New Haven, Connecticut 6520
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1275 York Ave
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Oakland, California 94611
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Oklahoma City, OK
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8200 Dodge St
Omaha, Nebraska 68114
(402) 955-5400
Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
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Omaha, NE
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Orlando, Florida 32803
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Orlando, FL
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