Table 1 Dose schedule for both study groups
GROUP I | Â | Â | Â |
|---|---|---|---|
Escalation Level | Study Time | Dose and route of administration | Duration |
Level 1 Total dose: 1 × 106 pfu | Day 1 | 5 × 105 pfu, intratumoral (via catheter) | 15 minutes |
|  | Day 10 | 5 × 105 pfu, intracerebal (direct injection at multiple locations of resection wall) | 15-30 minutes |
Level 2 Total dose: 5 × 107 pfu | Day 1 | 2.5 × 107 pfu, intratumoral (via catheter) | 15 minutes |
|  | Day 10 | 2.5 × 107 pfu, intracerebal (direct injection at multiple locations of resection wall) | 15-30 minutes |
Level 3 Total dose: 1 × 109 pfu | Day 1 | 5 × 108 pfu, intratumoral (via catheter) | 15 minutes |
|  | Day 10 | 5 × 108 pfu, intracerebral (direct injection at multiple locations of resection wall) | 15-30 minutes |
GROUP II | Â | Â | Â |
Escalation Level | Study Time | Dose and Route of Administration | Duration |
Level 1 Total dose: 1 × 106 pfu | Day 1 - 5 | 1 × 105 pfu, intravenous infusion | 2 hours |
|  | Day 10 | 5 × 105 pfu, intracerebral (direct injection at multiple locations of resection wall) | 15-30 minutes |
Level 2 Total dose: 5 × 107 | Day 1 - 5 | 0.5 × 107 pfu, intravenous infusion | 2 hours |
|  | Day 10 | 2.5 × 107 pfu, intracerebral (direct injection at multiple locations of resection wall) | 15-30 minutes |
Level 3 Total dose: 1 × 109 pfu | Day 1 - 5 | 1 × 108 pfu, intravenous infusion | 2 hours |
|  | Day 10 | 5 × 108 pfu, intracerebral (direct injection at multiple locations of resection wall) | 15-30 minutes |