Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM

Inclusion Criteria

• •1. Subject is a male or female 18 years of age or older.
• •2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).
• •3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.
• •4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.
• •5. Subject must be able to undergo MRI evaluation.
• •6. Subject meets the following laboratory criteria:
• •i. White blood count ≥ 3,000/μL ii. Absolute neutrophil count ≥ 1,500/μL iii. Platelets ≥ 100,000/μL iv. Hemoglobin \> 10.0 g/dL (transfusion and/or ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \< 1.5 x ULN
• •7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.
• •8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.
• •9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).