Clinical characteristics of the patients
| Lptn dose level* . | Patient . | Age, y/sex . | Tumor stage at diagnosis† . | No. prior treatments . | Relapse . | Time to first relapse, mo . | Site(s) of disease at vaccination . |
|---|---|---|---|---|---|---|---|
| 1 | 1 | 6/M | 4 | 3 | 1 | 21 | Bone, bone marrow |
| 1 | 2 | 3/M | 4 | 3 | 2 | 17 | Thorax, lymph node |
| 1 | 3 | 2/M | 3 | 2 | 1 | 34 | Bone, lymph node |
| 2 | 4 | 3.5/F | 4 | 2 | 1 | 47 | Bone |
| 2 | 5 | 6.5/M | 4 | 1 | 1 | 11 | Bone marrow |
| 2 | 6 | 4/M | 4 | 2 | Refractory disease | Bone, abdomen | |
| 3 | 7 | 3/M | 4 | 4 | 1 | 72 | Abdomen, thorax, bone, bone marrow |
| 3 | 8 | 17/F | 4 | 5 | 1 | 18 | Abdomen, bone marrow |
| 3 | 9 | 2/F | 4 | 1 | 1 | 4 | Abdomen, thorax, bone, bone marrow |
| 3 | 10 | 3/F | 4 | 4 | 1 | 18 | Abdomen, thorax, bone, bone marrow, lymph node |
| 3 | 11 | 4/F | 4 | 3 | Refractory disease | Bone, bone marrow | |
| 3 | 12 | 2/F | 4 | 5 | Refractory disease | Abdomen, thorax, bone, bone marrow, brain, lymph node | |
| 3 | 13 | 4/M | 4 | 2 | 1 | 36 | Abdomen, bone, bone marrow |
| 3 | 14 | 2/F | 4 | 2 | 1 | 31 | Abdomen, bone marrow |
| 3 | 15 | 3/M | 3 | 5 | 3 | 42 | Bone, bone marrow |
| 4 | 16 | 8/M | 3 | 3 | Refractory disease | Abdomen, bone marrow | |
| 4 | 17 | 5/M | 4 | 3 | 1 | 26 | Abdomen, thorax, bone, pelvis |
| 4 | 18 | 8/M | 4 | 3 | Refractory disease | Bone marrow, lymph node | |
| 4 | 19 | 9/M | 3 | 5 | Refractory disease | Abdomen, bone | |
| 4 | 20 | 2/M | 4 | 2 | 1 | 30 | Bone marrow |
| 4 | 21 | 10/M | 4 | 3 | Refractory disease | Adrenal gland, bone marrow |
| Lptn dose level* . | Patient . | Age, y/sex . | Tumor stage at diagnosis† . | No. prior treatments . | Relapse . | Time to first relapse, mo . | Site(s) of disease at vaccination . |
|---|---|---|---|---|---|---|---|
| 1 | 1 | 6/M | 4 | 3 | 1 | 21 | Bone, bone marrow |
| 1 | 2 | 3/M | 4 | 3 | 2 | 17 | Thorax, lymph node |
| 1 | 3 | 2/M | 3 | 2 | 1 | 34 | Bone, lymph node |
| 2 | 4 | 3.5/F | 4 | 2 | 1 | 47 | Bone |
| 2 | 5 | 6.5/M | 4 | 1 | 1 | 11 | Bone marrow |
| 2 | 6 | 4/M | 4 | 2 | Refractory disease | Bone, abdomen | |
| 3 | 7 | 3/M | 4 | 4 | 1 | 72 | Abdomen, thorax, bone, bone marrow |
| 3 | 8 | 17/F | 4 | 5 | 1 | 18 | Abdomen, bone marrow |
| 3 | 9 | 2/F | 4 | 1 | 1 | 4 | Abdomen, thorax, bone, bone marrow |
| 3 | 10 | 3/F | 4 | 4 | 1 | 18 | Abdomen, thorax, bone, bone marrow, lymph node |
| 3 | 11 | 4/F | 4 | 3 | Refractory disease | Bone, bone marrow | |
| 3 | 12 | 2/F | 4 | 5 | Refractory disease | Abdomen, thorax, bone, bone marrow, brain, lymph node | |
| 3 | 13 | 4/M | 4 | 2 | 1 | 36 | Abdomen, bone, bone marrow |
| 3 | 14 | 2/F | 4 | 2 | 1 | 31 | Abdomen, bone marrow |
| 3 | 15 | 3/M | 3 | 5 | 3 | 42 | Bone, bone marrow |
| 4 | 16 | 8/M | 3 | 3 | Refractory disease | Abdomen, bone marrow | |
| 4 | 17 | 5/M | 4 | 3 | 1 | 26 | Abdomen, thorax, bone, pelvis |
| 4 | 18 | 8/M | 4 | 3 | Refractory disease | Bone marrow, lymph node | |
| 4 | 19 | 9/M | 3 | 5 | Refractory disease | Abdomen, bone | |
| 4 | 20 | 2/M | 4 | 2 | 1 | 30 | Bone marrow |
| 4 | 21 | 10/M | 4 | 3 | Refractory disease | Adrenal gland, bone marrow |
The dose-escalation schedule began at 104Lptn-secreting tumor cells/kg body weight, increasing in log increments to 107 cells/kg body weight (108 cells/kg body weight maximum dose per injection). IL-2-secreting neuroblasts were administered at a fixed dosage (107 cells/kg body weight [108 cells/kg body weight maximum dose per injection]).
International Neuroblastoma Staging System (INSS) criteria.