Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma

To join this study, you would need to have been diagnosed with neuroblastoma, and it must be either a high-risk type that has come back after treatment, or hasn't responded to previous treatments.

Doctors would need to confirm your diagnosis using special tests, and your cancer must show up on scans like MRI, CT, or MIBG. It's important that you are generally well enough to take part and that your body's organs (like your heart, liver, and kidneys) are working properly. There are also specific rules about how much time must have passed since your last cancer treatment.

This study is for children and young people from age one upwards. The doctors on the study will carefully check all your medical information to make sure this trial is the right and safest option for you.

If you decide to take part, you would be randomly assigned to one of two groups: one group will receive the standard treatment combination (irinotecan, temozolomide, and dinutuximab) and the other group will receive the same combination plus the added drug eflornithine. This happens over treatment cycles, with each cycle lasting 21 days.

Throughout the study, you'll need to take some medicines by mouth, and others will be given through a drip (IV) into your vein. You'll have regular hospital visits for these treatments and check-ups. These visits will involve blood tests, scans (like MRI, CT, or PET), and sometimes bone marrow samples to see how the treatment is working. You might also be asked about any pain you experience. The treatment takes place over up to 6 cycles, which means it could last for several months. After the treatment period, there will be follow-up appointments to monitor your health. The medical team will explain all the details, including how long each visit might take and the total duration you'll be involved in the study.