Table 3. Pharmacokinetics and HACA response of ch14.18/CHO treated neuroblastoma patients.
Patient ID |
Course | Dosage (mg/m2/d) |
Tmax (h) |
Cmax (μg/ml) |
T 1/2 (h) |
AUC (μg/ml*h) |
V dis | HACA* | OD† (450nm) |
---|---|---|---|---|---|---|---|---|---|
| |||||||||
1 |
1 |
10 |
104.0 |
10.7 |
50.0 |
1483.4 |
2.5 |
- |
< 0.1 |
|
2 |
10 |
106.0 |
7.6 |
1.3 |
362.4 |
0.2 |
+ |
0.46 |
|
3 |
10 |
n.a. |
n.a. |
n.a. |
n.a. |
n.a. |
+ |
1.61 |
2 |
1 |
10 |
104.5 |
9.6 |
5.1 |
360.9 |
0.9 |
- |
< 0.1 |
|
2 |
10 |
104.0 |
2.5 |
208.5 |
91.8 |
121 |
- |
< 0.1 |
3 |
1 |
10 |
105.0 |
9.5 |
45.6 |
1236.6 |
2.8 |
+ |
0.26 |
|
2 |
10 |
104.5 |
9.0 |
10.1 |
350.1 |
2.6 |
+ |
1.51 |
4 |
1 |
20 |
112.0 |
26.6 |
n.a. |
1874.8 |
n.a. |
- |
< 0.1 |
5 |
1 |
20 |
104.0 |
16.9 |
121.7 |
4242.2 |
4.0 |
- |
< 0.1 |
|
2 |
20 |
10.0 |
23.0 |
140.1 |
6600.1 |
2.9 |
- |
< 0.1 |
6 |
1 |
20 |
108.0 |
15.0 |
102.5 |
2979.9 |
4.8 |
- |
< 0.1 |
|
2 |
20 |
104.0 |
19.7 |
55.6 |
2698.5 |
2.9 |
- |
< 0.1 |
7 |
1 |
20 |
106.0 |
13.6 |
196.5 |
2579.2 |
9.6 |
- |
< 0.1 |
|
2 |
20 |
104.5 |
14.2 |
203.6 |
1998.5 |
9.0 |
- |
< 0.1 |
|
3 |
20 |
104.0 |
12.9 |
51.6 |
1399.4 |
5.3 |
- |
< 0.1 |
8 |
1 |
20 |
10.0 |
7.4 |
75.5 |
1287.1 |
8.3 |
- |
< 0.1 |
|
2 |
20 |
104.0 |
14.4 |
38.1 |
1628.6 |
3.6 |
- |
< 0.1 |
9 |
1 |
20 |
8.5 |
21.3 |
40.0 |
2145.7 |
2.3 |
- |
< 0.1 |
|
2 |
20 |
104.0 |
12.8 |
23.7 |
1163.0 |
2.7 |
- |
< 0.1 |
10 |
1 |
20 |
104.5 |
19.8 |
25.6 |
1972.2 |
2.3 |
- |
< 0.1 |
|
2 |
20 |
104.0 |
9.7 |
4.9 |
182.7 |
5.8 |
+ |
0.14 |
|
3 |
20 |
104.0 |
9.7 |
4.5 |
259.8 |
3.4 |
+ |
1.28 |
11 |
1 |
20 |
96.5 |
11.6 |
135.7 |
4293.3 |
4.2 |
- |
< 0.1 |
|
2 |
20 |
104.0 |
5.6 |
n.a. |
46.5 |
n.a. |
- |
< 0.1 |
12 |
1 |
30 |
105.0 |
17.0 |
33.0 |
1302.2 |
3.6 |
- |
< 0.1 |
|
2 |
30 |
104.0 |
18.3 |
18.6 |
1356.0 |
2.3 |
- |
< 0.1 |
|
3 |
30 |
104.0 |
6.3 |
119.8 |
2163.9 |
11.7 |
- |
< 0.1 |
13 |
1 |
30 |
106.0 |
22.8 |
66.1 |
3375.3 |
4.2 |
- |
< 0.1 |
|
2 |
30 |
104.5 |
17.0 |
27.7 |
1623.1 |
3.7 |
- |
< 0.1 |
|
3 |
30 |
104.0 |
27.9 |
19.7 |
5801 |
3.1 |
- |
< 0.1 |
14 |
1 |
30 |
104.0 |
27.4 |
30.1 |
3527.9 |
1.9 |
- |
< 0.1 |
|
2 |
30 |
104.0 |
24.4 |
21.6 |
2260.4 |
2.2 |
- |
< 0.1 |
3 | 30 | 106.0 | 22.6 | 24.3 | 1772.7 | 2.7 | - | < 0.1 |
Legend: * positive (+) human anti-chimeric response corresponds with an OD 450 reading of > 0.1. † OD 450 values were given in HACA positive patients in subsequent courses. n.a. not available.