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

NCT07261241 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-12-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Radiation: 131I-MIBG

Patients will receive 131I-MIBG 18 mCi/kg (maximum dose 1200 mCi) on Day 1

DRUG

Dinutuximab

Dinutuximab 17.5 mg/m2/day is given intravenously on Days 8-11 and 29-32 of therapy

DRUG

Vorinostat

Vorinostat will be given on days 0-13 at a dose of 180 mg/m2/dose (maximum dose 400 mg).

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • Jubilant DraxImage Inc.

    collaborator INDUSTRY

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2030-07-31
Completion
2031-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07261241 on ClinicalTrials.gov