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|NCT03128047 : HUMC 1612: Optune NovoTTF-200A System|
|Ages||Min: 1 Year Max: 17 Years|
- Patients must have a minimum head circumference of 44 cm
- Patients must have a histologically- or cytologically-confirmed supratentorial
high-grade glioma (either WHO Grade III anaplastic astrocytoma or WHO Grade IV
glioblastoma multiforme). Patients in the initial cohort must have a tumor that is
progressive or recurrent to standard chemotherapy. Patients in the second cohort may
be newly diagnosed or have a tumor that is progressive, recurrent, or refractory to
- Patients must have received the maximal feasible resection of their tumor and
radiation therapy (unless contraindicated due to patient age) as part of their initial
treatment prior to study enrollment.
- Patients must be enrolled before treatment begins. Treatment must start within 14 days
of study enrollment.
- All clinical and laboratory studies to determine eligibility must be performed within
7 days prior to enrollment unless otherwise indicated in the eligibility section.
- Recurrent high-grade glioma patients must begin therapy within four weeks of
documented tumor progression by MRI scan. Newly-diagnosed patients must begin therapy
within six weeks of the completion of radiotherapy, or within six weeks of surgical
resection if radiotherapy is contraindicated.
- Patients must have a Lansky or Karnofsky performance status score of = 50%,
corresponding to ECOG categories of 0, 1 or 2. Use Karnofsky for patients > 16 years
of age and Lansky for patients = 16 years of age. 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.
- Able to undergo adequate tumor imaging, via magnetic resonance imaging (MRI) scan to
evaluate disease evolution.
- Adequate hematologic, renal, liver function as demonstrated by laboratory values: ANC
= 1,000/ul Hemoglobin =8.0 gm/dl Platelet count = 100,000/ul
Adequate Liver Function Defined As:
- Total bilirubin = 1.5 x upper limit of normal (ULN) for age, and
- SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age. Adequate Renal Function
Defined As Either
- Creatinine clearance or radioisotope GFR = 70ml/min/1.73m2
- or a serum creatinine less than or equal to the institutional normal for age
- Negative pregnancy test in women of childbearing potential within 7 days of initiating
- Recent mothers must agree not to breast feed while receiving medications on study
- Patient or legal guardian must give written, informed consent or assent (when
Additional Inclusion criteria for Cohort 2 (Optune NovoTTF-200A + chemotherapy) only:
- Able to swallow and ingest oral medication or have a NG or G-tube for drug
- Urine protein should be screened by urine analysis. If protein = 2+ on urinalysis,
then Urine Protein Creatinine (UPC) ratio should be calculated. If UPC ratio > 0.5,
24-hour urine protein should be obtained and the level should be < 1000 mg for patient
- Head circumference < 44 cm
- Infra-tentorial tumor
- Use of any other investigational drug within five half-lives of that drug prior to the
initiation of protocol therapy
- Anti-cancer therapy within 4 weeks prior to the initiation of protocol therapy (6
weeks for mitomycin and nitrosureas, 4 weeks for curative-intent radiotherapy, and 2
weeks for palliative radiotherapy)
- Any National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE
version 4.0) >Grade 1 toxicities from prior chemotherapy or radiotherapy that could
impact on safety outcome assessment
- Any surgery within 14 days prior to initiation of protocol therapy (excluding shunt or
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
implanted electronic devices in the brain, or documented clinically significant
- Evidence of increased intracranial pressure (midline shift > 5mm, clinically
significant papilledema, vomiting and nausea or reduced level of consciousness)
- Known > Grade 1 intracranial or intratumoral hemorrhage either by CT or MRI scan
within the last 1 month. Patients with resolving hemorrhage changes, punctuate
hemorrhage or hemosiderin may enter the study
- Pregnant female patients, Pregnancy tests with a negative result must be obtained in
all post-menarchal females.
- Lactating females must agree they will not breastfeed a child while on this study.
- Males and females of reproductive potential may not participate unless they agree to
use an effective contraceptive method and continue to do so for at least 6 months
after the completion of therapy.
- Any serious and/or unstable pre-existing medical, psychiatric or other condition which
in the Investigator's opinion could interfere with subject safety, obtaining written
informed consent, or compliance with the study protocol
Additional Exclusion criteria for Cohort 2 (Optune NovoTTF-200A + chemotherapy) only:
- Prior therapy with temozolomide and/or bevacizumab. The lone exception to this rule is
temozolomide and/or bevacizumab administered solely during radiation therapy.
- Known hypersensitivity to temozolomide or bevacizumab
- Patients who are unable to take oral medications because of significant uncontrolled
- Patients with a history of myocardial infarction, severe or unstable angina,
clinically significant peripheral vascular disease, Grade 2 or greater heart failure,
or serious and inadequately controlled cardiac arrhythmia
- Patients with known clinically significant bleeding diathesis or coagulopathy
- Patients who have experienced arterial thromboembolic events, including transient
ischemic attacks or cerebrovascular accidents
- Patients previously diagnosed with deep venous thrombosis (including pulmonary
embolism), and 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).
- History of an abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within the last 6 months prior to study entry.
- Patients with a serious or non-healing wound, ulcer, or bone fracture.
- History of allergic reaction to Chinese hamster ovary cell products, or other
recombinant human antibodies
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