Who can enter
• Children with high-risk neuroblastoma in whom the disease has not responded sufficiently to standard chemotherapy
Goal
The goal of this study is to further improve the treatment of patients with neuroblastoma who have not responded sufficiently to first standard chemotherapy. Two different treatment plans are being investigated in this study. First, we will examine whether the two treatment plans are effective and whether there are not too many side effects. Then the two treatment plans will be compared to determine which treatment plan results in the best outcome.
Background
In some children with high-risk neuroblastoma, the result of the first standard chemotherapy is not good enough to continue with the next part of treatment. An additional, more intensive treatment is needed to obtain a better treatment result.
Thus far, different treatments were given to children who had an insufficient result at this point in the treatment. Usually, additional courses of other chemotherapy or so-called 131I-mIBG therapy were chosen. The radioactive substance 131I-mIBG is attracted to the tumor cells and thereby irradiates the tumor cells from within the body for several days.
In this study we want to compare these two treatment plans. A random assignment ('randomization') determines which treatment plan the child will receive. Half of the children will receive one course of treatment with the drug thiotepa (chemotherapy), and the other half will receive treatment with 131I-mIBG and topotecan.
In addition, prior to the above treatment, all patients will receive three courses of TEM-IRI (temozolomide and irinotecan). After treatment with thiotepa or 131I-mIBG and topotecan, all patients will be treated with BuMel (busulfan and melphalan) followed by radiotherapy. After this, further treatment is discussed by the oncologist.