Conditions: Neuroblastoma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics \[UTC\] or the National Cancer Institute \[NCI\]).

Detailed description:
This is a multi-center, randomized, open-label, two-sequence, cross-over study for eligible subjects with high-risk neuroblastoma to assess the comparability of ch14.18 manufactured with UTC drug product and ch14.18 manufactured with NCI drug product. Subjects will be randomly allocated to receive ch14.18 manufactured by UTC or NCI during Courses 1 and 2 followed by ch14.18 manufactured by other manufacturer (UTC or NCI) during Courses 3, 4, and 5.

Arms:
arm 1: UTC ch14.18 for two courses and NCI ch14.18 for three courses arm 2: NCI ch14.18 for two courses and UTC ch14.18 for three courses

Interventions: intervention 1: ch14.18 -NCI intervention 2: ch14.18-UTC intervention 3: Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) intervention 4: Aldesleukin (IL-2) intervention 5: Isotretinoin
Intervention descriptions: intervention 1: 25 mg/m\^2/day IV for four consecutive days intervention 2: 17.5 mg/m\^2/day IV for four consecutive days intervention 3: GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5. intervention 4: Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m\^2/day for the first week and at a dose of 4.5 MIU/m\^2/day for the second week during Courses 2 and 4. intervention 5: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:

If weight \> 12 kg: 80 mg/m\^2/dose twice daily (total daily dose is 160 mg/m\^2/day, divided twice daily).

If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily).

Protocol document: