New Approaches to Neuroblastoma Therapy Consortium
Patients will then be randomized at study entry to one of three treatment arms. Patients on Arm A will receive a single treatment course with 131I-MIBG with vorinostat. Patients on Arm B will receive a single treatment course with 131I-MIBG and dinutuximab. Patients on Arm C will receive a single treatment course with 131I-MIBG with dinutuximab + vorinostat. After this course of treatment, we will check to see your response and then check to see how you are doing over time. All patients may choose to proceed to a second course of the same treatment if they and their physician feel healthy enough to do so. Approximately 118 patients will be receiving therapy on this trial.
The proposed study is a 3-arm randomized, pick-the-winner, phase 2 trial designed to identify the optimal combination 131I-MIBG treatment regimen for further study. The three treatment arms are 131I-MIBG + vorinostat; 131I-MIBG + dinutuximab; and 131I-MIBG + dinutuximab + vorinostat. Objective response rate following a single course of therapy will be the primary endpoint driving selection of the regimen to move forward into future studies.
Inclusion Criteria Age Patients must be ≥ 1 year and ≤31 years of age at the time of enrollment on the study. Diagnosis Patients must have a diagnosis of neuroblastoma by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines. Disease Risk Group Patients must have high risk neuroblastoma according to COG risk classification at the time of study registration. Patients whose disease was initially considered low or intermediate risk but then reclassified as high risk neuroblastoma prior to enrollment also meet this…
Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1
Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy
Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).