Table 1.
Selection Criteria
| Inclusion Criteria | Exclusion Criteria |
|---|---|
| Participants ≥18 years <65 years of age | Patients who are undergoing biopsy only or non-eligible for a surgical intervention |
| KPS ≥60 | Previous treatment with Bevacizumab |
| Negative pregnancy test done <7 days prior to registration, for persons of childbearing potential only | Radiographic evidence of leptomeningeal disease |
| Patients with a previous histological diagnosis of GBM that show recurrence at the same location, who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor. | |
| Patients have undergone previous standard of care as outlined by Stupp et al. (2004) which include maximal safe resection followed by concomitant radiation therapy and chemotherapy with oral temozolomide. | |
| Adequate organ function as assessed by the following laboratory values ≤3 weeks prior to registration: a. Serum creatinine and urea ≤2 times the upper limit of normal. b. ALT, AST and alkaline phosphatase ≤ 3 times the upper limit of normal, and bilirubin ≤ 2.5 mg/dL. c. Prothrombin time ≤ 1.5 times upper limit of normal d. INR and PTT ≤ 1.5 times the upper limit of normal. e. Hemoglobin ≥ 9 g/dL f. Platelets ≥ 100 × 109/L g. Absolute Neutrophil Count (ANC) ≥1.5 × 109/L. |
|
| Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) | |
| Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol | |
| Willingness to provide mandatory blood specimens for correlative research | |
| Willingness to provide mandatory tissue specimens for correlative research | |
| Willingness to undergo Ommaya reservoir placement and provide CSF samples for correlative research |