Pilot Study of Concomitant NovoTTF-200A and Temozolomide Chemoradiation for Newly Diagnosed Glioblastoma
This study is a prospective single arm trial designed to study the safety, feasibility and preliminary efficacy of a medical device, NovoTTF-200A used concomitantly with standard adjuvant treatment for newly diagnosed glioblastoma.
• Histologically confirmed GBM using WHO criteria.
• Age ≥ 18 years
• Maximal debulking surgery (at the discretion of the investigator). Biopsy alone is not exclusionary.
• KPS ≥ 70
• Life expectancy of at least 3 months.
• Sexually active participants must agree to the strict use of barrier contraception.
• Patients must be able to understand the investigational nature of the study and provide informed consent.
• Adequate hematologic function:
∙ Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
‣ Platelet count ) ≥ 100 x 109/L
‣ Hemoglobin ≥ 10 g /dL
• Adequate liver function
∙ Total bilirubin ≤ 1.5 x ULN
‣ AST and ALT ≤ 2.5 x ULN
⁃ Adequate renal function
⁃ a. Creatinine ≤ 1.25 x ULN
⁃ International normalized ratio (INR) or PT and activated partial thromboplastin time (aPTT): 1.5 x ULN (except for subjects receiving anticoagulation therapy). Use of anticoagulants is permitted as long as the INR or aPTT are within therapeutic limits (according to the medical standard of the institution).