Health Trials

Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

ConditionsGanglioneuroblastomaGanglioneuroblastoma, NodularNeuroblastoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age365-30
SponsorChildren's Oncology Group

About this trial

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.

Eligibility criteria

Qualifiers

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients must be enrolled on ANBL00B1 (NCT00904241) or APEC14B1 (NCT02402244) prior to enrollment on ANBL1531 (NCT03126916)

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patient must be >= 365 days and =< 30 years of age at diagnosis

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals), regardless of additional biologic features; OR

Age > 547 days regardless of biologic features

Disqualifiers

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with INRG stage L2 tumors without amplification of MYCN regardless of tumor histology (may meet criteria for high risk classification but are not eligible for this trial)

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients with bone marrow failure syndromes

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Patients for whom targeted radiopharmaceutical therapy would be contraindicated due to underlying medical disorders

FOR PATIENTS ENROLLING TO ANBL1531 (NCT03126916) WITHOUT PRIOR ANBL2131 (NCT06172296) ENROLLMENT: Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential

Trial design

Treatments tested in this trial

  • Autologous Hematopoietic Stem Cell Transplantation
  • Biospecimen Collection
  • Bone Marrow Aspiration and Biopsy
  • Busulfan
  • Carboplatin
  • Cisplatin
  • Computed Tomography
  • Cyclophosphamide
  • Dexrazoxane Hydrochloride
  • Dinutuximab
  • Doxorubicin Hydrochloride
  • Echocardiography Test
  • Etoposide Phosphate
  • External Beam Radiation Therapy
  • Iobenguane I-123
  • Iobenguane I-131
  • Isotretinoin
  • Lorlatinib
  • Magnetic Resonance Imaging
  • Melphalan Hydrochloride
  • Multigated Acquisition Scan
  • Positron Emission Tomography
  • Sargramostim
  • Therapeutic Conventional Surgery
  • Thiotepa
  • Topotecan Hydrochloride
  • Vincristine Sulfate

Treatment groups

750 Participants
are divided into 5 treatment groups

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov