drugset / Trial / NCT03649438
131I-Metaiodobenzylguanidine (131I-MIBG) Therapy for Relapsed/Refractory Neuroblastoma
Summary
This expanded access is the best available therapy/compassionate use designed to determine the palliative benefit and toxicity of 131I-MIBG in patients with relapsed/refractory neuroblastoma or metastatic pheochromocytoma who are not eligible for therapies of higher priority. Patients may receive a range of doses depending on stem cell availability and tumor involvement of bone marrow. Response rate, toxicity, and time to progression and death will be evaluated.
Timeline
- Start
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 131 I-Metaiodobenzylguanidine | Unknown | 10 mg/kg | Other |
| Subject | 131 I-Metaiodobenzylguanidine | Unknown | 12 mg/kg | Other |
| Subject | 131 I-Metaiodobenzylguanidine | Unknown | 18 mg/kg | Other |
| Background | G-CSF | Unknown | 5 ug/kg | Subcutaneous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | potassium iodide | Small molecule | 1 mg/kg | Oral |