The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation

• Adult patients ≥ 18 years old
• Newly diagnosed or recurrent high grade glioma (HGG) or glioblastoma (GBM) (if recurrent, prior pathology report indicating HGG or GBM)

• Adequate hematologic function within 14 days prior to starting evolocumab defined as follows:

  1. Hemoglobin ≥ 10 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable)
  2. Leukocytes ≥ 1,500/mm3
  3. Absolute Neutrophil Count (ANC) ≥ 1,000/mm3
  4. Platelets ≥ 100,000/mm3
• Adequate renal function within 14 days prior to starting evolocumab defined as calculated creatinine clearance (CrCL) of ≥ 30 mL/min/1.73m2 by the Cockcroft-Gault formula

• Adequate hepatic function within 14 days prior to starting evolocumab defined as follows:

  1. Total bilirubin ≥ 1.5 x institutional upper limit of normal (ULN) (Note: Patients with known Gilbert disease without other clinically significant liver abnormalities are not excluded.)
  2. AST(SGOT) and ALT(SGPT) ≥ 1.5 × ULN
• Negative serum pregnancy test (in females of childbearing potential) within 48 hours of starting evolocumab.

Exclusion Criteria:

• Any patient with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in evolocumab
• Patients with severe hepatic impairment outside of the range defined in the inclusion criteria within 7 days of starting evolocumab.
• History or evidence of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) not associated with any antitumor surgery within 6 months before enrollment
• Infection requiring intravenous antibiotics that was completed \< 1 week of study enrollment (day 1) with the exemption of prophylactic antibiotics for long line insertion or biopsy
• Females of reproductive potential and males who are unwilling to practice an acceptable method(s) of effective birth control while on study through 1 month (2 half-lives) after receiving the last dose of study drug.