Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma

Korábbi kezelés

• Prior radiation treatment to the brain
• Prior treatment with temozolomide

Más betegség

• Infratentorial disease (defined as glioblastoma [GBM] derived from cerebellum or brainstem)
• Implanted pacemaker, defibrillator or deep brain stimulator, or documented clinically significant arrhythmias
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study, in the opinion of the investigator
• Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
• Known active collagen vascular disease

Egyéb

• 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, clinically significant papilledema)

• 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's judgment; there must be a minimum of 21 days from the day of surgery to the day of protocol treatment; for core or needle biopsy, a minimum of 14 days must have elapsed 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 of normal range
• Women of childbearing potential must have a negative beta-human chorionic gonadotropin (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 and for 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 consent document. If the subject can comprehend the informed consent but is unable to sign, a LAR may sign the written informed consent document.