Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients With Non-high Risk Neuroblastoma

Summary

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Conditions

• Ganglioneuroblastoma
• Localized Resectable Neuroblastoma
• Localized Unresectable Neuroblastoma
• Neuroblastoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Carboplatin

Given IV

OTHER

Clinical Observation

Undergo clinical observation

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Ultrasound

Undergo ultrasound

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Holly J Meany · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-08

Primary Completion

2026-09-30

Completion

2026-09-30

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico
• Saudi Arabia

Study Locations