Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

Summary

This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.

Conditions

• Ganglioneuroblastoma
• Ganglioneuroblastoma, Nodular
• Neuroblastoma

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous HSCT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

DRUG

Busulfan

Given IV

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Cyclophosphamide

Given IV

DRUG

Dexrazoxane Hydrochloride

Given IV

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

DRUG

Etoposide Phosphate

Given IV

RADIATION

External Beam Radiation Therapy

Undergo EBRT

RADIATION

Iobenguane I-123

Given 123 I-MIBG

RADIATION

Iobenguane I-131

Given IV

DRUG

Isotretinoin

Given PO

DRUG

Lorlatinib

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Melphalan Hydrochloride

Given IV

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Positron Emission Tomography

Undergo PET scan

BIOLOGICAL

Sargramostim

Given SC

PROCEDURE

Therapeutic Conventional Surgery

Undergo standard of care surgery

DRUG

Thiotepa

Given IV

DRUG

Topotecan Hydrochloride

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Steven G DuBois · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

365 Days

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-14

Primary Completion

2030-09-30

Completion

2030-09-30

FDA Drug

Yes

Countries

• United States
• Canada
• Puerto Rico

Study Locations