Clinical Trial Details
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NCT00892177 : Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

Phase I: Histologic confirmation of grade 3 or 4 glioma, including astrocytoma,
oligodendroglioma, and mixed gliomas, as determined by pre-registration central pathology
review?Phase II: Histological confirmation of glioblastoma multiforme (grade 4
astrocytoma) as determined by pre-registration central pathology review; Note: Variant
gliosarcomas are eligible

- Evidence of tumor progression by magnetic resonance imaging (MRI) or computed
tomography (CT) scan; Note: Patients who have had surgical treatment at recurrence
are eligible if they had a subtotal resection with measurable or non-measurable
residual disease on postoperative imaging or if there is imaging evidence of disease
progression as compared to the first postoperative scan

- Measurable or evaluable disease by MRI or CT scan; Note: Patients who have had a
gross total resection (GTR) are eligible on the basis of evaluable disease

- ECOG performance status (PS) 0, 1, or 2

- Patient willing to discontinue use of aspirin or medications that inhibit platelet
function >= 1 week prior to registration

- Previous radiation therapy (RT) and >= 12 weeks since the completion of RT prior to

- Absolute neutrophil count (ANC) >= 1,500/mm^3

- Platelet count >= 100,000/mm^3

- Hemoglobin > 9.0 g/dL

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =<
3 x ULN

- Creatinine =< ULN

- Urine protein:creatinine (UPC) ratio < 1; NOTE: Urine protein must be screened by
urine analysis for UPC ratio; for UPC ratio >= 1.0, 24-hour urine protein must be
obtained and the level should be < 1000 mg

- Negative pregnancy test done =< 7 days prior to registration, for women of
childbearing potential only

- Ability to complete questionnaire(s) by themselves or with assistance

- Provide written informed consent

- Willingness to return to Alliance enrolling institution for follow-up

- Patient willing to provide mandatory tissue samples for research purposes

- Phase I: Any number of prior chemotherapy regimens for recurrent disease?Phase II: Up
to 2 prior chemotherapy regimens with =< 1 regimen for recurrent disease •>= 4 weeks
from prior chemotherapy, small molecule cell cycle inhibitors or other
investigational agents (>= 6 weeks from nitrosoureas) at the time of registration

Exclusion Criteria:

Any of the following: ?

- Pregnant women?

- Nursing women?

- Men or women of childbearing potential who are unwilling to employ adequate
contraception during this study and for up to 6 months after bevacizumab treatment
has ended

- Prior intratumoral therapy, stereotactic radiosurgery, or interstitial
brachytherapy; EXCEPTION: Separate lesion on MRI, which is not part of the
previous treatment field, or convincing evidence of recurrent disease, based on
biopsy, MRI spectroscopy, or positron emission tomography (PET) scan

- Prior treatment with bevacizumab or vascular endothelial growth factor
(VEGF)-Trap (aflibercept)

- Inadequately controlled hypertension (systolic blood pressure of > 150 mm Hg or
diastolic pressure > 100 mm Hg on anti-hypertensive medications); NOTE: Patients
with well-controlled hypertension are eligible

- Co-morbid systemic illnesses or other severe concurrent disease which, in the
judgment of the investigator, would make the patient inappropriate for entry
into this study or interfere significantly with the proper assessment of safety
and toxicity of the prescribed regimens

- Immunocompromised patients (other than that related to the use of
corticosteroids); Note: Patients known to be human immunodeficiency virus (HIV)
positive, but without clinical evidence of an immunocompromised state, are
eligible for this study

- Any condition (i.e., gastrointestinal tract disease resulting in an inability to
take oral medication or a requirement for IV alimentation, or prior surgical
procedures affecting absorption) that impairs ability to swallow pills

- Receiving therapeutic anticoagulation with warfarin; Note: Prophylactic
anticoagulation (i.e., low dose warfarin) of venous or arterial access devices
is allowed, provided that international normalized ratio (INR) < 1.5;
therapeutic anti-coagulation with low molecular weight heparin is allowed at
time of registration

- Evidence of bleeding diathesis (greater than normal risk of bleeding) or
coagulopathy (in the absence of therapeutic anticoagulation)

- Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection or psychiatric illness/social situations that would limit
compliance with study requirements

- Receiving any other investigational agent which would be considered as a
treatment for the primary neoplasm

- Other active malignancy =< 3 years prior to registration; EXCEPTIONS:
Non-melanotic skin cancer or carcinoma-in-situ of the cervix; Note: If there is
a history of prior malignancy, they must not be receiving other specific
treatment (other than hormonal therapy) for their cancer

- History of myocardial infarction or unstable angina =< 6 months prior to

- New York Heart Association (NYHA) classification II, III or IV congestive heart

- Core biopsy or other minor surgical procedures =< 7 days prior to registration;
Note: Placement of a vascular access device is allowed

- Major surgical procedure, open biopsy, or significant traumatic injury =< 28
days prior to registration or anticipation of need for major surgical procedure
during the course of the study

- Significant vascular disease (e.g., aortic aneurysm, aortic dissection) or
recent peripheral arterial thrombosis =< 6 months prior to registration

- History of hypertensive crisis or hypertensive encephalopathy

- Known hypersensitivity to any of the components of dasatinib or bevacizumab

- Serious, nonhealing wound, active ulcer, or untreated bone fracture

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess =< 6 months prior to registration

- Active or recent history of hemoptysis (>= ½ teaspoon of bright red blood per
episode) =< 30 days prior to registration

- History of stroke or transient ischemic attack (TIA) =< 6 months prior to

- Any evidence of central nervous system (CNS) hemorrhage on baseline CT or MRI

- Any of the following Category I drugs that are generally accepted to have a risk
of causing Torsades de Pointes =< 7 days prior to registration (patients must
discontinue drug 7 days prior to starting dasatinib)?* Quinidine, procainamide,
disopyramide?* Amiodarone, sotalol, ibutilide, dofetilide?* Erythromycin,
clarithromycin?* Chlorpromazine, haloperidol, mesoridazine, thioridazine,
pimozide?* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine,
domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin,
lidoflazine?* Prochlorperazine

- Diagnosed congenital long QT syndrome

- Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450

- Patients may not have any clinically significant cardiovascular disease
including the following:?* Myocardial infarction or ventricular tachyarrhythmia
within 6 months?* Prolonged QTc >= 480 msec (Fridericia correction)?* Ejection
fraction less than institutional normal?* Major conduction abnormality (unless a
cardiac pacemaker is present)

- Note: Patients with any cardiopulmonary symptoms of unknown cause (e.g.,
shortness of breath, chest pain, etc.) should be evaluated by a baseline
echocardiogram with or without stress test as needed in addition to
electrocardiogram (ECG) to rule out QTc prolongation; the patient may be
referred to a cardiologist at the discretion of the principal investigator;
patients with underlying cardiopulmonary dysfunction should be excluded from the

- Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to
dasatinib administration

- Known pleural or pericardial effusion of any grade

- Concomitant use of H2 blockers or proton pump inhibitors (PPIs) that cannot be
discontinued or switched to locally acting agents (i.e., famotidine or

- Use of the following enzyme inducing anti-convulsive (EIAC) medications is
prohibited =< 7 days prior to registration: carbamazepine (Tegretol, Tegretol
XR, Carbatrol), phenytoin (Dilantin, Phenytek), fosphenytoin (Cerebyx),
phenobarbital, pentobarbital and primidone (Mysoline); Note: Many antiepileptic
drugs induce hepatic enzymes; because dasatinib is metabolized by hepatic
enzymes, patients taking antiepileptic medications that induce hepatic enzymes
(EIACs) are ineligible for this trial; to be eligible for this trial, patients
taking EIACs must be switched to non-EIACs >= 7 days prior to registration; the
following agents are not known to affect dasatinib metabolism and are acceptable
for use: valproic acid (Depakote, Depacon), gabapentin (Neurontin), lamotrigine
(Lamictal), topiramate (Topamax), tiagabine (Gabitril), zonisamide (Zonegran),
levetiracetam (Keppra), clonazepam (Klonopin) and clobazam (Frisium)
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