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GanglioneuroblastomaChildren's healthProcedureDrugBiologicalRadiationPhase 3

What this study is

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.

What's being tested

  • Autologous Hematopoietic Stem Cell Transplantation

    Intervention · PROCEDURE

    Undergo autologous HSCT

  • Biospecimen Collection

    Intervention · PROCEDURE

    Undergo blood sample collection

  • Bone Marrow Aspiration and Biopsy

    Intervention · PROCEDURE

    Undergo bone marrow aspiration and biopsy

  • Busulfan

    Intervention · DRUG

  • Carboplatin

    Intervention · DRUG

  • Cisplatin

    Intervention · DRUG

  • Computed Tomography

    Intervention · PROCEDURE

    Undergo CT scan

  • Cyclophosphamide

    Intervention · DRUG

  • Dexrazoxane Hydrochloride

    Intervention · DRUG

  • Dinutuximab

    Intervention · BIOLOGICAL

  • Doxorubicin Hydrochloride

    Intervention · DRUG

  • Echocardiography Test

    Intervention · PROCEDURE

    Undergo echocardiography

  • Etoposide Phosphate

    Intervention · DRUG

  • External Beam Radiation Therapy

    Intervention · RADIATION

    Undergo EBRT

  • Iobenguane I-123

    Intervention · RADIATION

    Given 123 I-MIBG

  • Iobenguane I-131

    Intervention · RADIATION

  • Isotretinoin

    Intervention · DRUG

  • Lorlatinib

    Intervention · DRUG

  • Magnetic Resonance Imaging

    Intervention · PROCEDURE

    Undergo MRI

  • Melphalan Hydrochloride

    Intervention · DRUG

  • Multigated Acquisition Scan

    Intervention · PROCEDURE

    Undergo MUGA scan

  • Positron Emission Tomography

    Intervention · PROCEDURE

    Undergo PET scan

  • Sargramostim

    Intervention · BIOLOGICAL

    Given SC

  • Therapeutic Conventional Surgery

    Intervention · PROCEDURE

    Undergo standard of care surgery

  • Thiotepa

    Intervention · DRUG

  • Topotecan Hydrochloride

    Intervention · DRUG

  • Vincristine Sulfate

    Intervention · DRUG

All of Busulfan, Carboplatin, Cisplatin, Cyclophosphamide, Dexrazoxane Hydrochloride, Dinutuximab, Doxorubicin Hydrochloride, Etoposide Phosphate, Iobenguane I-131, Melphalan Hydrochloride, Thiotepa, Topotecan Hydrochloride, Vincristine Sulfate

Given IV

Both Isotretinoin and Lorlatinib

Given PO

Study details

Official title
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
Sponsor
Children's Oncology Group
Conditions
Ganglioneuroblastoma · Ganglioneuroblastoma, Nodular · Neuroblastoma
Enrolling
750 people
Starts
2018-05-14
Est. completion
2030-09-30
Design
Open-label, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗