Table 1.
Patient characteristics. vp, vector particles; NOS, not otherwise specified; KPS, Karnofsky performance score; LFTs, liver function tests; CRS, cytokine release syndrome; IDH, isocitrate dehydrogenase; MGMT, methylguanine methyltransferase.
| Ad–RTS–hIL-12 (2 × 1011 vp) | ||||
|---|---|---|---|---|
| 10-mg VDX n = 6 |
20-mg VDX n = 15 |
30-mg VDX n = 4 |
40-mg VDX n = 6 |
|
| Age (years): mean (min–max) | 49 (29–61) | 46 (26–68) | 60 (43–74) | 48 (36–58) |
| Gender (male:female) | 3: 3 | 10: 5 | 2: 2 | 4: 2 |
| Recurrence | ||||
| First | 2 | 4 | 1 | 2 |
| Second | 4 | 5 | 2 | 2 |
| Third or more | 0 | 6 | 1 | 2 |
| Prior lines of treatment (mean) | 2.0 | 2.2 | 3.0 | 2.5 |
| Prior bevacizumab | ||||
| Yes | 1 | 4 | 4 | 1 |
| No | 5 | 11 | 0 | 5 |
| Disease at study entry | ||||
| IDH–wild type GBM | 4 | 8 | 3 | 5 |
| IDH-mutant GBM | 1 | 3 | 0 | 1 |
| GBM, NOS | 0 | 2 | 1 | 0 |
| IDH–wild type astrocytoma | 1 | 0 | 0 | 0 |
| IDH-mutant astrocytoma | 0 | 2 | 0 | 0 |
| MGMT status | ||||
| Methylated | 1 | 5 | 2 | 3 |
| Unmethylated | 2 | 2 | 0 | 2 |
| Unknown | 3 | 8 | 2 | 1 |
| KPS at screening | ||||
| ≥90 | 3 | 9 | 2 | 4 |
| ≥70 and <90 | 3 | 6 | 2 | 2 |
| Steroid use within 4 weeks before first dose | ||||
| Yes | 3 | 8 | 2 | 4 |
| No | 3 | 7 | 1 | 2 |
| Unknown | 0 | 0 | 1 | 0 |
| Total steroid use (mg) | ||||
| Days 0 to 14 | 82 (0–102) | 48 (0–140) | 106 (0–136) | 49.5 (10–102) |
| Median (min–max) | ||||
| Veledimex dosing | 79 | 84 | 63 | 58 |
| Compliance (%) | ||||
| Dose-limiting toxicities contributing to assessment of maximum tolerated dose | — | Aseptic meningitis | CRS, elevated LFTs | |