Summary

Eligibility
for people ages up to 30 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

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)

Details

Keywords

Ganglioneuroblastoma, Neuroblastoma, Vitamin A, Cyclophosphamide, Melphalan, Busulfan, Thiotepa, Cisplatin, Carboplatin, Doxorubicin, Liposomal doxorubicin, Etoposide, Vincristine, Topotecan, Tretinoin, Etoposide phosphate, 3-Iodobenzylguanidine, Dinutuximab, Dexrazoxane, Razoxane, Isotretinoin, Sargramostim, Monoclonal Antibodies, Autologous Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration and Biopsy, Computed Tomography, Dexrazoxane Hydrochloride, Doxorubicin Hydrochloride, Echocardiography, External Beam Radiation Therapy, Iobenguane I-123, Iobenguane I-131, Lorlatinib, Magnetic Resonance Imaging, Melphalan Hydrochloride, Multigated Acquisition Scan, Positron Emission Tomography, Topotecan Hydrochloride, Vincristine Sulfate, chemotherapy, HSCT, EBRT, Iobenguane I-131, chemotherapy, HSCT, EBRT, Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT, lorlatinib, chemotherapy, HSCT, EBRT

Eligibility

Locations

  • UCSF Medical Center-Mission Bay
    San Francisco California 94158 United States
  • Kaiser Permanente-Oakland
    Oakland California 94611 United States
  • Valley Children's Hospital
    Madera California 93636 United States
  • Lucile Packard Children's Hospital Stanford University
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT03126916
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 724 study participants
Last Updated