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.
None
The minimum dose for peripheral blood stem cells is 1.5 x 10^6 viable CD34+ cells/kg. Patients who do not meet this minimum requirement for available PBSCs are not eligible.
For patients whose body weight exceeds ideal body weight (IBW) by more than 20%, adjusted body weight may be used for the calculation of PBSC dose.
ANC ≥750/uL (no short-acting granulocyte growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting granulocyte growth factors ≤ 14 days of blood draw documenting eligibility); and
Platelet count ≥ 50,0000/µl, transfusion independent (no platelet transfusions or platelet growth factors ≤ 7 days of blood draw documenting eligibility) Renal Function
New Approaches to Neuroblastoma Therapy Consortium
Lead sponsor
United Therapeutics
Collaborator
Jubilant DraxImage Inc.
Collaborator