Phase
Condition
Gliomas
Astrocytoma
Treatment
Radiation Therapy
Tumor Treating Fields Therapy
NovoTTF-200A Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with pathology confirmed newly diagnosed World Health Organization (WHO)grade IV glioma
Karnofsky performance status (KPS) ≥ 60
Patients must have recovered from the effects of surgery per treating physician'sjudgment; there must be a minimum of 21 days from the day of surgery to the day ofprotocol treatment; for core or needle biopsy, a minimum of 14 days must haveelapsed prior to the day of protocol treatment
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3
Platelets ≥ 100,000 cells/mm^3
Hemoglobin ≥ 9.0 g/dl
Creatinine clearance > 30 mL/min
Bilirubin < 2.0 mg/dL
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x upper limit ofnormal range
Women of childbearing potential must have a negative beta-human chorionicgonadotropin (HCG) pregnancy test documented within 14 days prior to registration
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry andfor 4 months after last dose of temozolomide
Is able to have magnetic resonance imaging (MRI) with contrast of the brain
All subjects must be able to comprehend and sign a written informed consentdocument. If the subject can comprehend the informed consent but is unable to sign,a LAR may sign the written informed consent document.
Exclusion
Exclusion Criteria:
Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum orbrainstem)
Implanted pacemaker, defibrillator or deep brain stimulator, or documentedclinically significant arrhythmias
A skull defect (such as, missing bone with no replacement)
Women of childbearing potential who are pregnant or breastfeeding
Evidence of increased intracranial pressure (midline shift > 5 mm, clinicallysignificant papilledema)
Serious medical or psychiatric illness likely to interfere with participation inthis clinical study, in the opinion of the investigator
Prior radiation treatment to the brain
Prior treatment with temozolomide
Known hypersensitivity to conductive hydrogels like the gel used onelectrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Known active collagen vascular disease
Study Design
Study Description
Connect with a study center
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available

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