Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma

Exclusion Criteria

• •1. Prior treatment with cytotoxic chemotherapy
• •1. Temozolomide (standard induction and / or maintenance dosing) within the past 4 weeks prior to planned infusion
• •2. "Metronomic" Temozolomide (low-dose, continuous administration) within the past 7 days prior to planned infusion
• •3. Nitrosoureas within the past 6 weeks prior to planned infusion
• •4. Treatment with any other cytotoxic agent within the past 4 weeks prior to planned infusion
• •2. Prior investigational treatment within the past 4 weeks or prior immunotherapy or antibody therapy within the past 4 weeks prior to planned infusion
• •3. Prior treatment with bevacizumab (Avastin) or other vascular-endothelial growth factor (VEGF) inhibitors or VEGF-receptor signaling inhibitors within the past 4 weeks prior to planned infusion
• •4. Prior therapy that included interstitial brachytherapy or Gliadel® Wafers (carmustine implants) within the past 12 weeks prior to planned infusion
• •5. Prior surgery (including stereotactic radiosurgery and biopsy procedures) within the past 4 weeks prior to planned infusion
• •6. Ongoing Optune© therapy within 5 days of planned infusion
• •7. Secondary GB (i.e., GB that progressed from low-grade diffuse astrocytoma or AA)
• •8. Known mutation in either the isocitrate dehydrogenase 1 (IDH1) or the IDH2 gene.
• •9. Tumor in the brainstem (not including fluid-attenuated inversion recovery \[FLAIR\] changes), an infratentorial tumor, diagnosis of gliomatosis cerebri (highly infiltrative T2 hyperintense tumor with ill-defined margins encompassing at least three lobes of the brain.
• •10. Tumor with a mass effect (e.g. 1-2 cm midline shift)
• •11. Subjects with tumors for which the preponderance of tissue is not of the type in which convection would be possible (e.g. preponderance of cystic component)
• •12. Tumor with geometric features that make them difficult to adequately cover the tumor volume with infusate by using CED catheters
• •13. Clinical symptoms that are thought by the Investigator to be caused by uncontrolled increased intracranial pressure, hemorrhage, or edema of the brain
• •14. Any condition that precludes the administration of anesthesia
• •15. Known to be human immunodeficiency virus positive
• •16. Concurrent or a history of any significant medical illnesses that in the Investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the subject's ability to tolerate the study drug therapy and/or put the subject at additional risk or interfere with the interpretation of the results of this trial
• •17. Known history of allergy to gadolinium contrast agents
• •18. Presence of another type of malignancy requiring treatment within \< 3 years prior to the screening visit, except for adequately treated carcinoma in-situ of the cervix, prostate cancer not actively treated, and basal or squamous cell carcinoma of the skin