Table 1.
Trial agents, doses, and schedule
Course | Chemotherapy | Immunotherapy |
---|---|---|
| ||
1 | Cyclophosphamide 400 mg/m2 i.v., days 1–5; Topotecan 1.2 mg/m2/d 1–5 i.v., days 1–5 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2a |
2 | Cyclophosphamide 400 mg/m2 i.v., days 1–5; Topotecan 1.2 mg/m2/d 1–5 i.v., days 1–5 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2a NK cells |
3 | Irinotecan 50 mg/m2 i.v., days 1–5 Temozolomide 150 mg/m2 p.o., days 1–5 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2b |
4 | Irinotecan 50 mg/m2 i.v., days 1–5 Temozolomide 150 mg/m2 p.o., days 1–5 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2b NK cells |
5 | Ifosfamide 2 g/m2 i.v., days 1–3 Carboplatin AUC-guided of 8 i.v., day 1 Etoposide 100 mg/m2 i.v., days 1–3 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2a |
6 | Ifosfamide 2 g/m2 i.v., days 1–3 Carboplatin AUC-guided of 8 i.v., day 1 Etoposide 100 mg/m2 i.v., days 1–3 |
hu14.18K322A 40 mg/m2 i.v., days 2–5 GM-CSF and IL2a NK cells |
NOTE: hu14.18K322A infusion over 4 hours unless rate decreased secondary to toxicity.
GM-CSF 250 mcg/m2/day s.q., day 7 through the nadir until ANC > 2,000/mm3; IL2 1 million units/m2 s.q. every other day for six doses (day 6, 8, 10, 12, 14, and 16).
GM-CSF 250 mcg/m2/day s.q., day 8 through the nadir until ANC > 2,000/mm3; IL2 1million units/m2 s.q. every other day for six doses (day 7, 9, 11, 13, 15, and 17). GM-CSF and IL2 start 1 day later in cycles 3 and 4 due to a delay in the NK-cell infusion to ensure that at least two half-lives of the active metabolite of irinotecan, SN-38, have elapsed.