Table 2.
No. of patients/No. of treatments | Dose level | BCNU concentration (mg/ml) | DTI-015 volume (as percentage Tv) | Total DTI-015 volume (ml) | Total BCNU dose (mg) |
4/5 | I | 12.5 | 25 | 0.6–2.0 | 7.5–25.0 |
5/5 | II | 12.5 | 50 | 2.1–8.3 | 26.25–103.0 |
10/13 | III | 12.5 | 75 | 0.7–10.5 | 8.75–131.25 |
5/5 | IV | 30 | 50 | 0.4–5.0 | 13.2–150 |
1/1 | V | 60 | 50 | 2.6 | 153 |
5/5 | VI | 45 | 75 | 1.4–7.6 | 63–342 |
8/8 | VII | 60 | 75 | 1.2–5.8 | 74–350 |
4/4 | VIII | 75 | 75 | 2.7–4.9 | 203–369 |
Forty patients received 46 treatments. Two patients received treatment at two dose levels, one patient received treatment at dose levels II and III, and one patient received treatment at dose levels VII and VIII. This accounts for the number of patients in column 1 totaling 42.