Condition: Neuroblastoma · Sponsor: St. Anna Kinderkrebsforschung
This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified \> 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patie…
This description comes directly from the study's public registry record.
Ruth L Ladenstein, MD, MBA, cPM · 0043140470 · ruth.ladenstein@ccri.at
Always discuss trial participation with your own doctor first.
| Women and Children´s Hospital | Adelaide, Australia | Recruiting |
| Lady Cilento Children´s Hospital | Brisbane, Australia | Recruiting |
| John Hunter Children's Hospital | Newcastle, Australia | Recruiting |
| Royal Children's Hospital Melbourne | Parkville, Australia | Recruiting |
| Sydney Children's Hospital | Sydney, Australia | Recruiting |
| Children´s Hospital Westmead | Westmead, Australia | Recruiting |
| St. Anna Kinderspital | Vienna, Austra, Austria | Recruiting |
| Univ.-Klinik für Kinder- und Jugendheilkunde Graz | Graz, Austria | Recruiting |
| Univ.Klinik f. Kinder-u. Jugendheilkunde Innsbruck | Innsbruck, Austria | Recruiting |
| Landes- Kinderklinik Linz | Linz, Austria | Recruiting |
| St. Johanns Spital LKH Salzburg | Salzburg, Austria | Recruiting |
| Cliniques universitaires St-Luc | Brussels, Belgium | Recruiting |
+ 114 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT01704716