Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 21
Updated:4/21/2016
Start Date:January 2012
End Date:March 2014

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A Phase II Study of Sunitinib (NSC# 736511) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients

This phase II trial studies how well sunitinib malate works in treating younger patients
with recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate
may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To estimate the objective response rate (partial response [PR] or complete response [CR]
≥ 8 weeks) to sunitinib in 2 strata (recurrent/progressive/refractory high-grade glioma vs
ependymoma) of recurrent or progressive brain tumors in pediatric and young adult patients.

SECONDARY OBJECTIVES:

I. To explore and report descriptively the safety and tolerability of sunitinib in pediatric
and young adult brain tumor patients who have not received prior anthracycline or
radiotherapy involving the heart.

II. To describe the pharmacokinetic profile of pediatric and young adult patients taking
sunitinib malate.

III. To describe the cumulative toxicities of sunitinib when administered over multiple
courses to pediatric and young adult patients.

IV. To estimate progression-free survival (PFS) distributions for these cohorts of patients.

V. To evaluate changes in phosphorylation of PDGFR-α and -β, MEK/ERK, S6 kinase, and AKT in
peripheral blood mononuclear cells and explore possible associations between these changes
and outcome measures.

VI. To evaluate plasma levels of soluble isoforms of VEGFR-1 and -2 prior to initiation of
therapy and at points during therapy as an exploration of possible biomarkers of clinical
response.

VII. To evaluate and report descriptively the expression and ratio of VEGF isoforms in tumor
tissue, as available.

VIII. To evaluate and report descriptively the genotype, expression, and possible
amplification of KIT and PDGFR-α and -β in tumor tissue, as available.

OUTLINE: This is a multicenter study.

Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment
repeats every 42 days for up to 18 courses in the absence of disease progression or
unacceptable toxicity.

Patients may undergo blood sample collection at baseline and during courses 1 and 2 for
pharmacokinetic and pharmacodynamic studies. Tissue samples from diagnosis and surgical
resection may be also collected.

After completion of study treatment, patients are followed up for up to 5 years.

Inclusion Criteria:

- Patients must be diagnosed with ependymoma or high-grade glioma (World Health
Organization [WHO] grade III/IV):

- Stratum A: recurrent/progressive/refractory malignant glioma (i.e., anaplastic
astrocytoma, glioblastoma multiforme [including giant cell and gliosarcoma
types], anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic
ganglioglioma) within the brain with or without spinal cord disease

- Stratum B: recurrent/progressive/refractory ependymoma (including ependymoma
variants) within the brain with or without spinal cord disease

- Patients with diffuse intrinsic pontine glioma are not eligible

- A histological diagnosis from either the initial presentation or at the time of
recurrence is required

- Patients must have radiographically documented measurable disease in the brain,
defined as at least one lesion that can be accurately measured in at least 2 planes

- To document the degree of residual tumor, the following must be obtained:

- All patients must have a brain MRI with and without gadolinium and a spine
magnetic resonance imaging (MRI), if clinically indicated,with and without
gadolinium, performed within 2 weeks prior to study enrollment

- Patients with evidence of new central nervous system (CNS) hemorrhage of more
than punctate size and/or more than 3 foci of punctate hemorrhage on baseline
MRI obtained within 14 days prior to study enrollment are not eligible

- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 (use
Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age)

- Neurological deficits in patients must have been relatively stable for a minimum
of 1 week prior to study enrollment; patients who are unable to walk because of
paralysis, but who are up in a wheelchair, will be considered ambulatory for the
purpose of assessing the performance score

- Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL

- Platelet count ≥ 75,000/μL (transfusion independent, defined as not receiving
platelet transfusions within the 7-day period prior to enrollment)

- Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min OR
serum creatinine based on age/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)

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

- Serum glutamic oxaloacetic transaminase (SGOT/AST) and serum glutamic pyruvic
transaminase (SGPT/ALT) ≤ 2.5 times ULN

- Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction of ≥ 50% by
radionuclide angiogram

- Corrected QT interval < 450 msec (males) or < 470 msec (females)

- Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 times ULN

- Partial thromboplastin time (PTT) ≤ 1.5 times ULN

- Patients must not have a history of cardiac disease including, but not limited to:

- Uncontrolled hypertension within 12 months prior to enrollment; uncontrolled
hypertension is defined as follows:

- Patients aged ≤ 17 years: greater than 95th percentile systolic and
diastolic blood pressure based on age and height which is not controlled by
one anti-hypertensive medication

- Patients aged > 17 years: systolic blood pressure ≥ 140 mm Hg and/or
diastolic blood pressure ≥ 90 mm Hg which is not controlled by one
anti-hypertensive medication

- Ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade

- Unstable angina, symptomatic congestive heart failure, or myocardial infarction

- Patients with a seizure disorder may be enrolled if on non-enzyme-inducing
anticonvulsants and well controlled

- Commonly used non-enzyme-inducing anticonvulsants include: gabapentin,
lamotrigine, levetiracetam, tiagabine, topiramate, valproic acid, and zonisamide

- Patients must not have had a cerebrovascular accident or transient is chemic attack
within 12 months prior to enrollment

- Patients must not have had a pulmonary embolism or other significant thromboembolic
event within 12 months prior to enrollment

- Patients must not have had grade ≥ 3 hemorrhage within 4 weeks prior to enrollment

- Patients must not have had any of the following diagnoses within 6 months prior to
enrollment: peptic ulcer disease, inflammatory bowel disease, or diverticulitis

- Patients with a diagnosis of abdomen fistula, gastrointestinal (GI) perforation, or
intra-abdominal abscess within 6 months prior to enrollment are not eligible

- Patients who have an uncontrolled infection are not eligible

- Patients with hypothyroidism that has not been well-controlled by medications for at
least 2 weeks prior to study entry are not eligible

- Patients who have a personal history of genetic and/or congenital cardiac
abnormalities are not eligible

- Patients who have a history of allergic reactions to compounds of similar chemical or
biological composition to sunitinib are not eligible

- Patients who have any other condition that could result in an inability to swallow
capsules/sprinkles or absorb oral sunitinib administered through a gastric tube are
not eligible

- Patients with body surface area < 0.55 m^2 or > 2.18 m^2 are not eligible

- Female patients who are pregnant are not eligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative
pregnancy test result has been obtained within the past 4 weeks

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation

- No concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs), clopidogrel,
warfarin, heparin, low molecular weight heparin, dipyridamole, or aspirin therapy >
81 mg/day

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy (RT) prior to entering this study

- Must not have received myelosuppressive chemotherapy within 3 weeks of entry onto
this study (6 weeks if prior nitrosourea)

- At least 7 days since the completion of therapy with a biologic agent; for agents
that have known adverse events occurring beyond 7 days after administration, this
period must be extended beyond the time during which adverse events are known to
occur

- At least 3 half-lives must have elapsed since prior therapy that included a
monoclonal antibody

- At least 24 weeks must have elapsed if prior full-field RT

- ≥ 2 weeks must have elapsed if prior local palliative RT (small port) or
limited-field RT

- ≥ 3 months must have elapsed since prior stem cell transplant (SCT) or rescue
with total-body irradiation (TBI)

- No evidence of active graft-vs-host disease

- Patients who are receiving dexamethasone must be on a stable or decreasing dose for
at least 7 days prior to enrollment

- Patients must not have received potent cytochrome P450-3A4 (CY3A4) inhibitors and/or
inducers within 7 days prior to study enrollment and potent inducers within 12 days
prior to study enrollment and during study

- At least 7 days must have elapsed since the completion of therapy with a
hematopoietic growth factor

- Patients who have previously received sunitinib or who have received other VEGF-,
PDGFR-, or KIT-targeted therapy are not eligible

- Patients who received bevacizumab as part of their prior therapy may enroll on
study

- Patients must not have received more than 2 prior chemotherapy and/or RT regimens;
for example, 1 initial treatment course of chemotherapy and/or RT (counts as 1
treatment course) and at relapse may have received 1 treatment course of chemotherapy
and/or RT (counts as 1 treatment course)

- Patients who received prior therapy with known risk for cardiovascular complications
(e.g., anthracycline therapy or prior RT that included the heart and/or craniospinal
radiation) are not eligible

- Patients receiving ongoing treatment with therapeutic doses (i.e., therapeutic INR
levels) of coumarin derivatives or oral anti-vitamin K agents are not eligible

- Patients receiving antiretroviral therapy for human immunodeficiency virus (HIV)
disease are not eligible

- Patients who are started on protocol therapy on a phase II study prior to study
enrollment are considered ineligible

- No other concurrent chemotherapy, investigational agents, or immunomodulating agents

- No concurrent RT
We found this trial at
87
sites
282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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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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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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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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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
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(616) 722-2000
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3533 South Alameda Street
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7777 Forest Ln # C840
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1200 Pleasant Street
Des Moines, Iowa 50309
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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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1200 Moursund Street
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(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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2500 N State St
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(601) 984-1000
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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(816) 234-3000
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
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4650 Sunset Blvd
Los Angeles, California 90027
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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231 E Chestnut St
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(502) 629-6000
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9300 Valley Children's Pl
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(559) 353-3000
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262 Danny Thomas Pl
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(901) 495-3300
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Orange, California 92868
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1717 South Orange Avenue # 100
Orlando, Florida 32806
(407) 650-7000
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
(850) 505-4700
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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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
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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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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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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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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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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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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Charlotte, North Carolina 28204
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
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Chicago, Illinois 60614
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Dayton, Ohio 45404
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
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
Hackensack, New Jersey 07601
(201) 996-2000
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
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2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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Jacksonville, Florida 32207
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Milwaukee, Wisconsin 53226
Midwest Children's Cancer Center The Medical College of Wisconsin Cancer Center is dedicated to providing...
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2450 Riverside Ave
Minneapolis, Minnesota 55454
(612) 273-3000
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
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Morristown, New Jersey 07962
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1275 York Ave
New York, New York 10021
(212) 639-2000
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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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Orlando, Florida 32803
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725 Welch Rd
Palo Alto, California 94304
(650) 497-8000
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Philadelphia, Pennsylvania 19104
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Randwick, New South Wales 2031
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, Missouri 63141
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84143
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San Francisco, California 94143
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Savannah, Georgia 31404
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1305 W 18th St
Sioux Falls, South Dakota 57117
(605) 333-1000
Sanford USD Medical Center - Sioux Falls Sanford
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Overlook Hospital Atlantic Health System
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311 Martin Luther King Jr Way
Tacoma, Washington 98403
(253) 403-1400
Mary Bridge Children's Hospital and Health Center Mary Bridge Children's Hospital was established in 1955,...
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2142 N Cove Blvd
Toledo, Ohio 43606
(419) 291-5437
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Washington, District of Columbia
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
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Winston-Salem, NC
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