Neural Stem Cells-expressing CRAd-S-pk7

PRIMARY OBJECTIVE: I. Determine the recommended maximum tolerated number of cycles (MTC) of intracavitary (ICT) administered neural stem cell-expressing CRAd-S-pk7 (NSCCRAd-S-pk7) for phase II testing based on dose-limiting toxicities (DLTs), the overall toxicity profile, and activity in patients with recurrent high-grade glioma (HGG). II.

Describe and compare the weekly dosing schedule (Treatment Schedule 4) to an every 2 week dosing schedule (Treatment Schedule 4a) of intracerebrally administered NSC-CRAd-S-pk7 based on DLTs, the overall toxicity profile, and activity in patients with glioblastoma at first recurrence. III. Determine the recommended phase 2 dose schedule based on the overall toxicity profile, and activity in patients with recurrent high grade gliomas SECONDARY OBJECTIVES: I. I.

This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.

Live record on ClinicalTrials.gov →

• Patient must be age \>= 18 years
• Patient has a Karnofsky performance status of \>= 70%
• Patient has a life expectancy of \>= 3 months
• When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3 oligodendroglioma). (This part of the study has been completed).
• When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence.
• Imaging studies show evidence of recurrent, supratentorial tumor(s).

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.