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MIBG With Dinutuximab +/- Vorinostat

NCT03332667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-04-16

Study results available
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Summary

131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial, 131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6 patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose level. A 6 patient expansion cohort may then be enrolled.

Conditions

Interventions

RADIATION

131I-MIBG

Patients will receive 131I-MIBG on day 1. 131I-MIBG dose will be based on the dose level assigned at the time of patient registration

DRUG

Dinutuximab

Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab dose will be based on the dose level assigned at the time of patient registration.

DRUG

Vorinostat

Vorinostat will be given on day 0-13. Vorinostat dose will be based on the dose level assigned at the time of patient registration.

DRUG

Sargramostim

Sargramostim (GM-CSF) will be given on day 8-17 at 250 mcg/m\^2

DRUG

Potassium Iodide

Potassium iodide will be given by mouth at a dose of 6mg/kg 8-12 hours prior to infusion of 131I-MIBG on Day 1 and then 1mg/kg/dose by mouth starting 4-6 hours after completion of MIBG infusion and continuing every 4 hours on protocol days 1-7 and then 1mg/kg/dose by mouth once daily on protocol days 8-45

Sponsors & Collaborators

  • United Therapeutics

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • New Approaches to Neuroblastoma Therapy Consortium

    lead OTHER

Principal Investigators

  • Thomas Cash, MD · Children's Healthcare of Atlanta

  • Araz Marachelian, MD, MS · Children's Hospital Los Angeles

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2024-02-23
Completion
2024-02-23
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 NCT03332667 on ClinicalTrials.gov