NANT 2021-02: Randomized MIBG With Vorinostat/Dinutuximab/Vorinostat + Dinutuximab

Starting soon · Phase 2

Conditions studied: Neuroblastoma

In brief

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.

Key facts

Study ID

NCT07261241

Run by

New Approaches to Neuroblastoma Therapy Consortium

People needed

118

Starts

2026-07-31

Expected to finish

2031-07-31

Last updated by the study team

2025-12-03

Who can join

Age: 1 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age Patients must be ≥ 1 year and < 30 years of age at the time of study registration.
• Diagnosis Patients must have a diagnosis of neuroblastoma or ganglioneuroblastoma nodular subtype either 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 who were initially considered low or intermediate risk, but then reclassified as high risk are also eligible.
• 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 minor 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 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)
• The minimum dose for peripheral blood stem cells is 1.5 x 106 viable CD34+ cells/kg. Patients who do not meet this minimum requirement for available PBSCs are not eligible.
• Only un-purged stem cells are allowed unless a center has separate FDA approval for infusion of purged stem cells.
• 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.47
• Performance level Patients must have a Lansky (≤ 16 years) or Karnofsky (> 16 years) score of ≥ 50 Note: Subjects 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 of all prior chemotherapy, immunotherapy, 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:
• ANC ≥750/uL (no short-acting hematopoietic growth factors ≤ 7 days of blood draw documenting eligibility and no long-acting hematopoietic 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 a. Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age Liver Function
• Total bilirubin ≤ 1.5 x ULN for age; and,

You may not qualify if…

• 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.
• Patient declines participation in NANT 2004-05, the NANT Biology Study.
• 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.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Children Hospital of Colorado — Aurora, Colorado, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Memorial Hospital - Chicago — Chicago, Illinois, United States
• Childrens Hospital Boston, Dana-Farber Cancer Institute. — Boston, Massachusetts, United States
• C.S Mott Children's Hospital — Ann Arbor, Michigan, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Cook Children's Medical Center - Fort Worth — Fort Worth, Texas, United States
• Children's Hospital and Regional Medical Center - Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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