Completed PHASE1 INTERVENTIONAL 1-arm NCT01175356

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

A COG Pilot Study of Intensive Induction Chemotherapy and 131I-MIBG Followed by Myeloablative Busulfan/Melphalan (Bu/Mel) for Newly Diagnosed High-Risk Neuroblastoma

Sponsor: Children's Oncology Group

Conditions Ganglioneuroblastoma Localized Resectable Neuroblastoma Localized Unresectable Neuroblastoma Regional Neuroblastoma Stage 4 Neuroblastoma Stage 4S Neuroblastoma

Interventions 3-Dimensional Conformal Radiation Therapy Autologous Hematopoietic Stem Cell Transplantation Busulfan Cisplatin Cyclophosphamide Doxorubicin Hydrochloride Etoposide Phosphate External Beam Radiation Therapy In Vitro-Treated Peripheral Blood Stem Cell Transplantation Intensity-Modulated Radiation Therapy Iobenguane I-131 Isotretinoin Laboratory Biomarker Analysis Melphalan Pharmacological Study Questionnaire Administration Therapeutic Conventional Surgery Topotecan Hydrochloride Vincristine Sulfate

Updated 15 times since 2017 Last updated: Jan 6, 2026 Started: Dec 21, 2011 Primary completion: Sep 28, 2016 Completion: Dec 31, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Ganglioneuroblastoma and Localized Resectable Neuroblastoma, this trial is completed. The trial is conducted by Children's Oncology Group and has accumulated 15 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

15 versions recorded

Feb 2026 — Present [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Sep 2025 — Feb 2026 [monthly]

Active Not Recruiting PHASE1
Feb 2025 — Sep 2025 [monthly]

Active Not Recruiting PHASE1
Sep 2024 — Feb 2025 [monthly]

Active Not Recruiting PHASE1
Jul 2024 — Sep 2024 [monthly]

Active Not Recruiting PHASE1

▶ Show 10 earlier versions

Feb 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE1
May 2023 — Feb 2024 [monthly]

Active Not Recruiting PHASE1

Phase: NA → PHASE1
Apr 2022 — May 2023 [monthly]

Active Not Recruiting NA
Apr 2021 — Apr 2022 [monthly]

Active Not Recruiting NA

Status: Completed → Active Not Recruiting
Jan 2021 — Apr 2021 [monthly]

Completed NA
Jun 2018 — Jan 2021 [monthly]

Completed NA
Oct 2017 — Jun 2018 [monthly]

Completed NA
Sep 2017 — Oct 2017 [monthly]

Completed NA
Feb 2017 — Sep 2017 [monthly]

Completed NA

Status: Active Not Recruiting → Completed
Jan 2017 — Feb 2017 [monthly]

Active Not Recruiting NA

First recorded

Dec 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Children's Oncology Group
National Cancer Institute (NCI)

Data source: Children's Oncology Group

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Atlanta, United States , Aurora, United States , Birmingham, United States , Boston, United States , Chapel Hill, United States , Charleston, United States , Chicago, United States , Cincinnati, United States , Dallas, United States and 13 more locations