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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03189706 | Study of Chemoimmunotherapy for High-Risk Neuroblastoma | EARLY_PHASE1 | ACTIVE NOT_RECRUITING | 48 | — | — | Jun 12, 2017 | Jun 1, 2026 | Jul 2, 2025 | 1 | United States |
The regimen will be considered safe if there are no toxicities requiring discontinuation of therapy in at least 9/10 patients during the first two cycles.
Response assessment will be based on the best response over the course of four cycles. Disease response for NB will use the International NB Response Criteria. Patients who withdraw from the study prior to cycle 4 with \< partial response will also not be considered evaluable for response and will be replaced.
| Arm | Type | Description |
|---|---|---|
| Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS) | EXPERIMENTAL | Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF. |
| Name | Type | Description |
|---|---|---|
| Irinotecan | DRUG | 50mg/m\^2/day IV will be administered from day 1-5 |
| temozolomide | DRUG | (given concurrently with Irinotecan) 150mg/m\^2/day orally |
| Hu3F8 | BIOLOGICAL | 2.25mg/kg IV will be administered on days 2, 4, 8 and 10 |
| GM-CSF | DRUG | 250mcg/m2/day SC will be administered on days 6-10 |
Inclusion Criteria: * Diagnosis of NB as defined by international criteria,.e., histopathology (confirmed by the MSK Department of Pathology) or bone marrow metastases plus high urine catecholamine levels * High-risk NB as defined as any of the following: * Stage 4 with MYCN amplification (any a...