Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01592045 | ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma | PHASE1 | COMPLETED | 28 | — | — | Aug 1, 2012 | Jun 1, 2014 | Sep 23, 2015 | 13 | United States |
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin
Twenty-two PK samples will be obtained at the following timepoints: Courses 1 and 3: Day: 0 Days: 3, 4, 5 and 6: post ch14.18 Days 7:10 to 14 hours post ch14.18 Days 9 to 11: Single sample Days 14 to 17: Single sample Courses 2 and 4: Day 0: Pre-IL-2 Day 7: Pre-ch14.18 Day 10 (Course 4 only): Post ch14.18 End of Treatment: Within 2 weeks post isotretinoin
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | UTC ch14.18 for two courses and NCI ch14.18 for three courses |
| Sequence 2 | EXPERIMENTAL | NCI ch14.18 for two courses and UTC ch14.18 for three courses |
| Name | Type | Description |
|---|---|---|
| ch14.18 -NCI | BIOLOGICAL | 25 mg/m\^2/day IV for four consecutive days |
| ch14.18-UTC | BIOLOGICAL | 17.5 mg/m\^2/day IV for four consecutive days |
| Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) | BIOLOGICAL | GM-CSF will be administered SC at a dose of 250 mcg/m\^2/day for 14 days during Courses 1, 3, and 5. |
| Aldesleukin (IL-2) | BIOLOGICAL | 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. |
| Isotretinoin | DRUG | 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). |
Inclusion Criteria: * Diagnosis of high-risk neuroblastoma * 8 years of age or younger at diagnosis of high-risk neuroblastoma * Patients must have completed therapy including intensive induction followed by autologous stem cell transplantation (ASCT) and radiotherapy \* Radiotherapy may be waiv...