MINT
Research type
Research Study
Full title
A biomarker enriched phase I/II clinical trial of 131I-MIBG therapy with talazoparib for the treatment of relapsed and/or refractory neuroblastoma.
IRAS ID
1010040
Contact name
Sally George
Contact email
Sponsor organisation
The University of Birmingham
ISRCTN Number
ISRCTN64894508
Research summary
The MINT study is a clinical trial for children/young adults with neuroblastoma which has not responded to initial treatment (relapsed/refractory).
Neuroblastoma is the most common solid tumour occurring outside the brain in childhood. Neuroblastoma remains a significant cause of cancer-related death in children. More than 2250 cases per year are diagnosed in North America, Canada and Europe. Overall survival is below 50% and there is a need to develop new treatment strategies.
131I-MIBG therapy, a form of targeted radiotherapy, is a well-established and effective treatment for neuroblastoma. However, response rates vary and it is unclear which patients are most likely to benefit. A class of targeted drugs (called PARP inhibitors) have been shown to act as a radio-sensitiser (make the cancer cells more sensitive to radiation) in laboratory studies. Adding a PARP inhibitor to 131I-MIBG therapy may be an effective treatment for relapsed or refractory neuroblastoma. It may also be effective in treating neuroblastoma with specific mutations in certain genes. These gene mutations make it harder for neuroblastoma cells to repair DNA after being damaged.
In this study, participants will be treated with a drug called talazoparib (a PARP inhibitor) in combination with 131I-MIBG therapy. The participants will be split into two groups, depending on whether they have specific gene mutations. The study will look at whether these mutations could indicate how well the talazoparib increases the effect of the 131I-MIBG therapy. The study will also determine the recommended dose of talazoparib by monitoring side effects.
The study hopes to recruit 42 participants in the UK, Netherlands, Germany and Canada, over 3.5 years.
All participants will receive one course of talazoparib with 131I-MIBG and a stem cell rescue infusion. Participants will be followed up for at least 2 years after the treatment to understand disease response and side effects.REC name
East of England - Essex Research Ethics Committee
REC reference
25/EE/0158
Date of REC Opinion
12 Sep 2025
REC opinion
Further Information Favourable Opinion