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MIBG With Dinutuximab +/- Vorinostat
Phase 1 trial testing 131I-MIBG in Neuroblastoma in 45 participants. Completed in 23 February 2024.
| Lead sponsor | New Approaches to Neuroblastoma Therapy Consortium |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 12 September 2018 |
| Primary completion | 23 February 2024 |
| Estimated completion | 23 February 2024 |
| Sites | 12 locations across United States |
New Approaches to Neuroblastoma Therapy Consortium
Adults 1 to 30, any sex, with Neuroblastoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of patients with Course 1 DLT in Cohort A
| Group | Value | 95% CI |
|---|---|---|
| Cohort A DL1 | 0 | |
| Cohort A DL2 | 0 | |
| Cohort A DL3 | 0 |
Proportion of patients with Course 1 DLT in Cohort B
| Group | Value | 95% CI |
|---|---|---|
| Cohort B DL4 | 1 |
Proportion of patients with any grade 3 or greater non-hematological toxicities in Cohort A
| Group | Value | 95% CI |
|---|---|---|
| Cohort A DL1 | 5 | |
| Cohort A DL2 | 3 | |
| Cohort A DL3 | 10 |
Proportion of patients with any grade 3 or greater non-hematological toxicities in Cohort B
| Group | Value | 95% CI |
|---|---|---|
| Cohort B DL4 | 12 |
Proportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in Cohort A
| Group | Value | 95% CI |
|---|---|---|
| Cohort A DL1 | 2 | |
| Cohort A DL2 | 4 | |
| Cohort A DL3 | 5 |
Proportion of patients evaluable for response with a best overall response of CR/CR-MD/PR for patients in Cohort B
| Group | Value | 95% CI |
|---|---|---|
| Cohort B DL4 | 5 |
Time frame: All adverse events from enrollment through 30 days following end of protocol therapy, up to 5 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort A DL1 | Cohort A DL2 | Cohort A DL3 | Cohort B DL4 |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Jejunal obstruction | Gastrointestinal disorders | — | — | — | — |
| Oral pain | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| Allergic reaction | Immune system disorders | — | — | — | — |
| Sepsis | Infections and infestations | — | — | — | — |
| Infusion related reaction | Injury, poisoning and procedural complications | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Spinal cord compression | Nervous system disorders | — | — | — | — |
| Urinary retention | Renal and urinary disorders | — | — | — | — |
| Urinary tract pain | Renal and urinary disorders | — | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Cohort A DL1 | Cohort A DL2 | Cohort A DL3 | Cohort B DL4 |
|---|---|---|---|---|---|
| White blood cell decreased | Investigations | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Pain | General disorders | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — | — | — |
| Sinus tachycardia | Cardiac disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Hypotension | Vascular disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Facial pain | General disorders | — | — | — | — |
| Bruising | Injury, poisoning and procedural complications | — | — | — | — |
| Weight loss | Investigations | — | — | — | — |
| Hyperphosphatemia | Metabolism and nutrition disorders | — | — | — | — |
| Agitation | Psychiatric disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Eosinophilia | Blood and lymphatic system disorders | — | — | — | — |
| Sinus bradycardia | Cardiac disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Hypermagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
Most-reported serious reactions: Dehydration, Abdominal pain, Fever, Anemia, Febrile neutropenia, Diarrhea, Jejunal obstruction, Oral pain.
Data from ClinicalTrials.gov NCT03332667 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03332667.
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