A Phase 2 interventional study of Radiation: 131I-MIBG and Dinutuximab in Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium. Not yet recruiting at 13 sites in United States. Open to participants aged 1 Year to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by New Approaches to Neuroblastoma Therapy Consortium · Phase 2, Interventional, and Treatment
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.
625 studies on the registry are indexed under Neuroblastoma; 123 are open to participants now.
This study's planned enrollment of 118 is above the median of 32 across 475 interventional studies indexed under Neuroblastoma.
Browse Neuroblastoma studies →New Approaches to Neuroblastoma Therapy Consortium is the lead sponsor of 23 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 criteria.
Response to Prior Therapy (using INRC definitions)
Patients must have at least ONE of the following:
Recurrent/progressive disease after the diagnosis of high-risk neuroblastoma at any time prior to enrollment - regardless of response to frontline therapy. (Note that this excludes patients initially considered low or intermediate-risk that progressed to high-risk disease but have not progressed after the diagnosis of high-risk neuroblastoma).
If no prior history of recurrent/progressive disease since the diagnosis of high-risk neuroblastoma,
Refractory disease: A best overall response of no response/stable disease since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy.
Persistent disease: A best overall response of partial response since diagnosis of high-risk neuroblastoma AND after at least 4 courses of induction therapy:
i. If a patient with persistent disease has 3 or more MIBG avid sites (including all soft tissue and/or bone lesions) OR a Curie Score of ≥ 3, then no biopsy is required for eligibility.
ii. If a patient with persistent disease has only 1 or 2 MIBG avid sites (including all soft tissue and/or bone lesions) then biopsy confirmation of neuroblastoma and/or ganglioneuroblastoma in at least one MIBG avid site (bone marrow, bone, or soft tissue) present at the time of registration is required. Bone and/or soft tissue lesions may be biopsied at any time point prior to study registration; bone marrow must be done at the time of study registration.
Sites of Disease: MIBG Uptake Patients must have evidence of MIBG uptake by planar imaging into tumor at ≥ 1 site (bone or soft tissue) within 21 days prior to study entry and subsequent to any intervening therapy. See exclusion criteria.
Autologous peripheral blood stem cells (PBSC)
Performance Status Patients must have a Lansky (≤ 16 years) or Karnofsky (> 16 years) score of ≥ 50.
Note: Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
Prior Therapy
Patients must have fully recovered from the acute toxic effects and beyond the washout period of all prior chemotherapy, immunotherapy (monoclonal antibodies [MOAB], bi-/tri-specific antibody T-cell engagers, and cellular therapy) or radiotherapy prior to study registration.
Organ Function Requirements
Hematologic Function:
Patients must meet the following hematologic criteria for enrollment regardless of bone marrow disease involvement:
a. Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age:
Liver Function
Central Nervous System (CNS) Function:
Cardiac Function
Pulmonary Function No evidence of dyspnea at rest, no exercise intolerance, or oxygen requirement.
Reproductive Function
Exclusion Criteria
Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study due to risks of fetal and teratogenic adverse events.
Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring or radiation isolation requirements of the study.
Patients with disease of any major organ system that would compromise their ability to withstand therapy.
Patients must not have received prior allogeneic stem cell transplant.
Patients who have received prior solid organ transplantation.
Patients must not have received prior total body irradiation.
Patients who are on hemodialysis.
Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture negative, afebrile, and meet other organ function criteria.
Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C. Testing is not required in the absence of clinical findings or suspicion.
Patients with a history of having to permanently discontinue anti-GD2 antibody therapy, GM-CSF, or vorinostat due to toxicity are not eligible.
Patients who have received prior MIBG in combination with anti-GD2 monoclonal antibody and/or histone deacetylase inhibitor
The maximum total allowable dose of 131I-MIBG that can be given per institutional guidelines must be at least 90% of the calculated or protocol maximum 131I-MIBG dose or the patient is not eligible.
Patients with a history of deep venous thrombosis that was not associated with the presence of a central venous catheter.
Only for institutions that have not been granted a waiver by NANT:
Patients with evidence of active MIBG non-avid disease; patients with previously treated and stable disease that is not MIBG avid are still eligible.
Patients whose best response post previous MIBG therapy was progressive disease.
Patients with a cumulative lifetime dose of 131I-MIBG greater than 20 mCi/kg.
Patients assigned to Arm A will receive vorinostat orally once daily on Days 0 to 13 at a dose of 180 mg/m2/dose (maximum dose 400 mg). Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1 and autologous stem cell infusion on Day 15 (plus 2 days or minus 1 day, hereafter abbreviated as +2/-1 days). There must be at least 24 hours between the last dose of vorinostat and stem cell infusion. Disease evaluation is to occur between days 43-57. The time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.
Drug: Radiation: 131I-MIBG · Drug: Vorinostat
Patients assigned to Arm B will receive 18 mCi/kg (maximum dose 1200 mCi) 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15 (+2/-1 days). Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy. Disease evaluation is to occur between Days 43-57. In case of treatment delays with dinutuximab during Course 1, the time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.
Drug: Radiation: 131I-MIBG · Drug: Dinutuximab
Patients assigned to Arm C will receive vorinostat 180 mg/m2/dose (maximum dose 400 mg) on Days 0 to 13, 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. Disease evaluation is to occur between Days 43-57. In case of treatment delays with dinutuximab during Course 1, the time interval between performing end of Course 1 disease evaluation and administration of Course 2 131I-MIBG is not to exceed 4 weeks.
Drug: Radiation: 131I-MIBG · Drug: Dinutuximab · Drug: Vorinostat
Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1
Also known as: Iobenguane I 131
Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy
Also known as: Chimeric Monoclonal Antibody 14.18, Chimeric MOAB 14.18, human/murine anti-GD2 monoclonal antibody, chimeric anti-GD2, chimeric mAb 14.18, ch14.18, Unituxin
Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).
Also known as: Zolinza
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.
Time frame: 43-57 days from study day 1
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
Time frame: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months
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.
Time frame: 43-57 days from study day 1
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.
Time frame: 43-57 days from study day 1
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.
Time frame: 43-57 days from study day 1
Objective Soft Tissue Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest soft tissue 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.
Time frame: 43-57 days from study day 1
Objective Soft Tissue Tumor Response After Two Courses of Therapy
To identify the MIBG treatment regimen associated with the highest soft tissue 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.
Time frame: 43-57 days from study day 1
Objective Bone Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest bone 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.
Time frame: 43-57 days from study day 1
Objective Bone Tumor Response After Two Courses of Therapy
To identify the MIBG treatment regimen associated with the highest bone 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.
Time frame: 43-57 days from study day 1
Objective MIBG Tumor Response After One Course of Therapy
To identify the MIBG treatment regimen associated with the highest MIBG 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.
Time frame: 43-57 days from study day 1
Objective MIBG Tumor Response After Two Courses of Therapy
To identify the MIBG treatment regimen associated with the highest MIBG 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.
Time frame: 43-57 days from study day 1
Plan to share: Undecided
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New Approaches to Neuroblastoma Therapy Consortium