Who can enter
- Children and adolescents with neuroblastoma in whom the disease has returned (relapse) or responded insufficiently to standard treatment (refractory)
- Age: 18 months up to 18 years
The aim of this research is to improve the survival and quality of life of children with high-risk neuroblastoma. In this study we want to look at a new targeted radiotherapy. In this study, we look at the new radioactive agent 177Lutetium DOTATATE, Lutathera ®.
The main goal is to confirm the dose and assess the response to treatment with the drug lutetium-177(177Lu)-DOTATATE in children and adolescents with relapsed neuroblastoma or neuroblastoma that has not responded sufficiently to standard treatment. We will also evaluate long-term survival and disease response. In addition, we will record and assess side effects of treatment.
Neuroblastoma is known to be a disease that is sensitive to radiation. With conventional radiotherapy, radiation is shot from the outside through the body to the tumor. With targeted molecular radiotherapy, radiation is specifically delivered only into the tumor via a radioactive drug. This is an attractive treatment option because the radiation specifically targets the tumor. And with the same administration, all tumors throughout the body can be treated.
Studies on tumor tissues have shown that most neuroblastomas have the so-called ‘somatostatin receptors’. The drug 177Lu-DOTATATE specifically targets these receptors and can bind to them. 177Lu-DOTATATE has been shown to be effective in treating neuroendocrine tumors with these receptors in adults. Initial results from the use of 177Lu-DOTATATE in the treatment of children and adolescents with neuroblastoma are encouraging.
A previous study with this drug (LuDO) demonstrated that 177Lu-DOTATATE was safe. However, at the dose and dosing schedule given, it did not appear to be effective. In this study (LuDO-N), the goal is to determine whether 177Lu-DOTATATE can be effective if treatment is given in a shorter timeframe. This involves giving a maximum of two doses approximately two weeks apart.