Predicting Response Patterns to Treatment in Glioblastoma (GBM) Patients

Prior treatment

• Any concurrent and/or other active malignancy that has required systemic treatment within 2 years of surgery. Except for basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to screening, and carcinoma in situ of the cervix that have been completely excised and cured at least 5 years prior to screening.
• Participation in another clinical trial which includes an investigational drug.

Other illness

• Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.

Other

• Pregnancy.

• Provision of informed consent prior to any study-specific procedures.
• Male or female aged at least 18 years.
• KPS not less than 50.
• Normal hematologic, renal and liver function:
  • Absolute neutrophil count above 1500/mm3, platelets above 100,000/mm3, hemoglobin above 9 g/dL;
  • Creatinine concentration not more than 1.4 mg/dL, or creatinine clearance above 40 mL/min;
  • Total bilirubin below 1.5 mg/dL, ALT+ AST levels not more than 3 times above the upper normal limit.
• Patients planned to receive standard of care TMZ+RT treatment; TTF therapy during RT is permitted.