Table 1.

Trial agents, doses, and schedule

CourseChemotherapyImmunotherapy
1Cyclophosphamide 400 mg/m2 i.v., days 1–5;hu14.18K322A 40 mg/m2 i.v., days 2–5
Topotecan 1.2 mg/m2/d 1–5 i.v., days 1–5GM-CSF and IL2a
2Cyclophosphamide 400 mg/m2 i.v., days 1–5;hu14.18K322A 40 mg/m2 i.v., days 2–5
Topotecan 1.2 mg/m2/d 1–5 i.v., days 1–5GM-CSF and IL2a
NK cells
3Irinotecan 50 mg/m2 i.v., days 1–5hu14.18K322A 40 mg/m2 i.v., days 2–5
Temozolomide 150 mg/m2 p.o., days 1–5GM-CSF and IL2b
4Irinotecan 50 mg/m2 i.v., days 1–5hu14.18K322A 40 mg/m2 i.v., days 2–5
Temozolomide 150 mg/m2 p.o., days 1–5GM-CSF and IL2b
NK cells
5Ifosfamide 2 g/m2 i.v., days 1–3hu14.18K322A 40 mg/m2 i.v., days 2–5
Carboplatin AUC-guided of 8 i.v., day 1GM-CSF and IL2a
Etoposide 100 mg/m2 i.v., days 1–3
6Ifosfamide 2 g/m2 i.v., days 1–3hu14.18K322A 40 mg/m2 i.v., days 2–5
Carboplatin AUC-guided of 8 i.v., day 1GM-CSF and IL2a
Etoposide 100 mg/m2 i.v., days 1–3NK cells
  • NOTE: hu14.18K322A infusion over 4 hours unless rate decreased secondary to toxicity.

  • aGM-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).

  • bGM-CSF 250 mcg/m2/day s.q., day 8 through the nadir until ANC > 2,000/mm3; IL2 1 million 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.