drugset / Trial / NCT07261241
NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab
Phase 2
Not yet recruiting
118 enrolled
New Approaches to Neuroblastoma Therapy Consortium
Jubilant DraxImage Inc. · collabUnited Therapeutics · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.
Timeline
- Start
- 2026-07-31
- Primary completion
- 2030-07-31
- Completion
- 2031-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 131I-MIBG | Protein / enzyme biologic | 18 mbq/kg | — |
| Subject | Dinutuximab | Monoclonal antibody | 17.5 mg/m2 | Intravenous |
| Subject | Vorinostat | Small molecule | 180 mg/m2 | Oral |