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| Diagnosis | Neuroblastoma | Study Status | Closed to enrollment |
| Phase | II |
| Age | Child, Adult - (2 Years to 30 Years) | Randomisation | YES |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Vorinostat (oral); vincristine, irinotecan and 131I-MIBG are given intravenously. |
| Last Posted Update | 2021-09-03 |
| ClinicalTrials.gov # | NCT02035137 |
International Sponsor
New Approaches to Neuroblastoma Therapy ConsortiumPrincipal Investigators for Canadian Sites
The Hospital for Sick Children – Dr. Meredith IrwinCentres
Study Description
This study is specifically for patients diagnosed with relapsed or persistent neuroblastoma.
Metaiodobenzylguanidine (MIBG) is a compound that can be combined with radioactive iodine (I-131) to deliver targeted radiation therapy. Oncologists use to deliver targeted radiation to neuroblastoma. I-131 MIBG is administered to a child through an intravenous line and is absorbed by tumor cells, which are killed by radiation emitted by the radioactive I-131.
The three treatment arms are the following:
- 131 I-MIBG therapy alone
- 131 I-MIBG therapy with Irinotecan and Vincristine: The two chemotherapy medications irinotecan and vincristine, which are known to be active agents for neuroblastoma, are given at the same time as the 131I-MIBG, and may make the 131I-MIBG more effective at treating neuroblastoma.
- 131 I-MIBG with Vorinostat: Vorinostat is a drug that is FDA-approved to treat a certain type of cancer mainly seen in adults. Vorinostat affects the way the DNA that carries our genes is folded in cells. In the laboratory, vorinostat causes neuroblastoma cells to stop growing. This effect is even greater when vorinostat is combined with radiation. Giving vorinostat together with the 131I-MIBG may make the 131I-MIBG more effective at treating neuroblastoma.
Why is this study being done?
- To find out which of the three 131I-MIBG treatment arms have a better tumor response rate
- To compare the side effects seen with 131I-MIBG alone, compared with 131I-MIBG in combination with Vincristine and Irinotecan or 131I-MIBG with Vorinostat.
- To describe the number of patients found to have tumor cells in the blood and bone marrow using a new sensitive test following each of the three 131I-MIBG treatment arms.
- To compare the exposure of whole body radiation from 131I-MIBG received on the three treatment arms.
- To learn about a new computerized way of reading MIBG scans.
Inclusion Criteria
(From NANT website - https://www.nant.org/n2011-01/)
- Patients must be at least 24 months and no older than 30 years of age
- Patients must have relapsed neuroblastoma, refractory neuroblastoma or persistent neuroblastoma
- Patients must have at least one site of tumor with MIBG uptake based on an MIBG scan done within 4 weeks prior to entry on study
- Patients must have an adequate number of peripheral blood stem cells available.
- Patients must have adequate organ function.
- Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team
