Table 1.
Demographics and dose escalation for the phase I study
| 131I-omburtumab dose (MBq) | Number planned in the absence of DLT | Number of patients enrolled | No. receiving at least one Rx dose | Number of NB | Number of other diagnoses** | Median actual dose received (mCi/MBq) | Number of patients treated with 2 cycles |
|---|---|---|---|---|---|---|---|
| 370 | 3 | 5c,d | 3 | 1 | 2 | 10/370 | 1 |
| 740 | 3 | 3 | 3 | 1 | 2 | 20.6/762.2 | 3 |
| 1110 | 3 | 61 | 6b | 5 | 1 | 30.3/1121.1 | 4 |
| 1480 | 3 | 3 | 3 | 1 | 2 | 40/1480 | 2 |
| 1850 | 3 | 6c,e | 6 | 3 | 3 | 49.6/1835.2 | 3 |
| 2220 | 3 | 4e | 4 | 3 | 1 | 58.1/2149.7 | 1 |
| 2590 | 6 | 6a | 6 | 1 | 5 | 69.9/2586.3 | 2 |
| 2960 | 6 | 5 | 5 | 0 | 5 | 79.4/2937.8 | 1 |
| Total | 30 | 38 | 36 | 15 | 21 | 17 |
DLT dose-limiting toxicity, NB neuroblastoma
aOne patient at this dose level received age-based dose reduction per protocol
bOne patient at this dose level with DLT
cOne patient replaced because treatment dose was not administered due to rapid disease progression after the first imaging dose
dOne patient replaced because treatment dose was not administered due to non-compliance after the first imaging dose
eAdditional patients treated on compassionate basis after IRB approval
**Other diagnoses (n = 21) included medulloblastoma (n = 6), ependymoma, (n = 3), melanoma and rhabdomyosarcoma (n = 3 each), choroid plexus carcinoma (n = 2), and atypical rhabdoid teratoma, chordoma, pineoblastoma and retinoblastoma (n = 1 each)