drugset / Trial / NCT03332667
MIBG With Dinutuximab +/- Vorinostat
Phase 1
Completed
45 enrolled
New Approaches to Neuroblastoma Therapy Consortium
National Cancer Institute (NCI) · collabUnited Therapeutics · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.
Timeline
- Start
- 2018-09-12
- Primary completion
- 2024-02-23
- Completion
- 2024-02-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Vorinostat | Small molecule | 180 mg/m2 | Oral |
| Background | potassium iodide | Unknown | 1 mg/kg | Oral |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |