Tumor Treating Fields, Stereotactic Radiosurgery, and Temozolomide for the Treatment of Newly Diagnosed Glioblastoma

Inclusion Criteria

• Histopathologically proven newly diagnosed glioblastoma (GBM, WHO grade 4) or molecular GBM of lower grade that will be treated as per glioblastoma (defined as IDH wild type, 1p19q not co deleted) or grade 4 astrocytoma
• Age >= 18 years
• A maximum tumor target diameter of less than 5 cm on the post operative magnetic resonance imaging (MRI) used for SRS planning (a 5 mm margin is added in the radiotherapy planning process, yielding a maximum diameter of the planning target volume (PTV) of less than 6 cm). If the maximum diameter is greater than 5 cm, the subject is still eligible if the PTV is less than 113 cm3 which is the volume of a 6 cm diameter sphere
• Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without myeloid growth factor support for 7 days preceding the lab assessment (obtained within 14 days prior to day 0)
• Hemoglobin (Hgb) >= 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if hemoglobin is corrected to >= 9 g/dL (90 g/L) as by growth factor or transfusion prior to day 0 (obtained within 14 days prior to day 0)
• Platelet count >= 100 x 10^9/L without blood transfusions for 7 days preceding the lab assessment (obtained within 14 days prior to day 0)
• Bilirubin =< 1.5 x upper limit of normal (ULN), except for subjects with documented history of Gilbert’s disease (obtained within 14 days prior to day 0)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x ULN (obtained within 14 days prior to day 0)
• Alkaline phosphatase (AP) =< 3 x ULN (obtained within 14 days prior to day 0)
• Women of childbearing potential (WCBP): negative serum pregnancy test (this test is required of all women unless post menopausal, defined as 12 consecutive months since last regular menses or surgically sterile) (obtained within 14 days prior to day 0)
• Ability to tolerate MRI
• Karnofsky performance status (KPS) >= 60
• Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written Institutional Review Board (IRB) approved informed consent document

Exclusion Criteria

• Previous chemotherapy or radiotherapy for glioma
• Concurrent use of experimental therapies
• Known allergy to adhesive tapes or other skin adhesives used in medical care
• Known underlying skin hypersensitivity or other condition of the scalp with potential toxicity per pre treatment dermatology evaluation
• Subjects with the following co morbid disease or incurrent illness: * Subjects with known cirrhosis diagnosed with Child Pugh class A or higher liver disease. * Prior malignancy except for non melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to first dose of investigational drug * Severe/uncontrolled inter current illness within the previous 28 days prior to first day of treatment * Subjects who have implantable devices that are contra indicated for use with TTFields * Any other significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
• Subjects receiving the following medications at the time of combined TTFields and SRS: * Pharmacotherapy for tuberculosis or human immunodeficiency virus (HIV) as these medications are known to interact with temozolomide * Other chemotherapy, other investigational agents, or biologic agents for the treatment of cancer including antibodies (e.g., bevacizumab, trastuzumab, pertuzumab), small molecules, or any investigational agent(s).
• Pregnant or nursing females will be excluded from the study
• History of inability to tolerate MRI