Best overall response
a | ||||||
DL 14 mg/kgN = 3 | DL 28 mg/kgN = 3 | DL 316 mg/kgN = 3 | DL 432 mg/kgN = 6 | OverallN = 15 | ||
Stable disease (N, %) | 3 (100%) | 2 (67%) | 2 (67%) | 4 (67%) | 11 (73%) | |
Progressive disease (N, %) | 0 (0%) | 1 (33%) | 1 (33%) | 2 (33%) | 4 (27%) | |
b | ||||||
Patient # | Tumor type | Dose (mg/kg) | Time on study (months)* | Best response | Off treatment reason | IL-8 level decrease |
1 | Colorectal | 4 | 3.5 | SD | Patient choice | |
2 | Prostate | 4 | 2 | SD | Patient choice | x |
3 | Chordoma | 4 | 8 | SD | Patient choice | |
4 | Chordoma | 8 | 13 | SD | Patient choice | |
5 | Colorectal | 8 | 1.5 | PD | Progression | |
6 | Esophageal | 8 | 7 | SD | Progression | x |
7 | Chondrosarcoma | 16 | 1 | PD | Progression | x |
8 | Chordoma | 16 | 5.5 | SD | Progression | |
9 | Chordoma | 16 | 5.5 | SD | Patient choice | x |
10 | Papillary thyroid | 32 | 5.5 | SD | Patient choice | x |
11 | Colorectal | 32 | 4.5 | SD | Patient choice | x |
12 | Prostate | 32 | 8 | SD | Patient choice | x |
13 | Colorectal | 32 | 7 | SD | Patient choice | x |
14 | Ovarian | 32 | 1.5 | PD | Progression | x |
15 | Chordoma | 32 | 2 | PD | Progression | x |
Best overall response. a Best overall response by dose level and overall are shown. b Responses are shown by tumor type and dose level in addition to time on study and reason for withdrawal from study treatment. Three patients had adverse events leading to their decision to come off the study. Decreases in IL-8 are also noted
DL dose level; IL-8 interleukin-8; SD stable disease; PD progressive disease