Clinical Trial Details
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[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.]

NCT01462695 : Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma
PhasePhase 2
AgesMin: 1 Year Max: 21 Years
Eligibility
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 MRI,
if clinically indicated,with and without gadolinium, performed within 2 weeks
prior to study enrollment

- Patients with evidence of new 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

- 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/?L

- Platelet count ? 75,000/?L (transfusion independent, defined as not receiving
platelettransfusions within the 7-day period prior to enrollment)

- Hemoglobin ? 8.0 g/dL (may receive RBC transfusions)

- Creatinine clearance or radioisotope 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)

- SGOT (AST) and 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)

- PT/INR ? 1.5 times ULN

- 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: pepticulcer 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 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., anthracyclinetherapy 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 derivativesor oral anti-vitamin K agents are not eligible

- Patients receiving antiretroviral therapy for 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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01462695      |      Link to official Clinicaltrials.gov listing
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