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
Parallel
Radiation: 131I-MIBG
DrugPatients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1
Dinutuximab
DrugDinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy
Vorinostat
DrugVorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).
Objective Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Number of Participants With Grade 3 or Greater Non-hematologic Toxicities
Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; 131I-MIBG with vorinostat; 131I-MIBG with dinutuximab; or 131I-MIBG with vorinostat and dinutuximab
Objective Tumor Response After Two Courses of Therapy
To identify the MIBG treatment regimen associated with the highest overall response rate after two courses of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Objective Bone Marrow Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest bone marrow response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Objective Bone Marrow Tumor Response After Two Courses of Therapy
To identify the MIBG treatment regimen associated with the highest bone marrow response rate after two courses of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
Click on the lead sponsor to view all of their trials.
New Approaches to Neuroblastoma Therapy Consortium
Lead sponsor
United Therapeutics
Collaborator
Jubilant DraxImage Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
