Table 1.
Dose schedule for both study groups
| GROUP I | |||
|---|---|---|---|
| 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 | |||
| 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 | |
Specification of virus application and dose escalation during the Parvoryx01 trial: dose group 2 will be treated after completion of group 1 and after interim analysis of safety and tolerability in group 1.