Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)

Summary

This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They may also affect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.

Conditions

• Ganglioneuroblastoma, Nodular
• Neuroblastoma

Interventions

PROCEDURE

Biospecimen Collection

Correlative studies

PROCEDURE

Bone Marrow Aspiration

Undergo BM aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo BM biopsy

PROCEDURE

Computed Tomography

Undergo CT

BIOLOGICAL

Dinutuximab

Given IV

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

RADIATION

Iobenguane I-123

Undergo 123I-MIBG

DRUG

Irinotecan

Given IV

DRUG

Isotretinoin

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Sargramostim

Given SC or IV

DRUG

Temozolomide

Given PO or via enteral tube

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Ami V Desai · Children's Oncology Group

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-31

Primary Completion

2023-06-30

Completion

2027-09-30

FDA Drug

Yes

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations