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

Conditions

• Ganglioneuroblastoma
• Ganglioneuroblastoma, Nodular
• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

365 Days - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo autologous HSCT
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration and Biopsy — PROCEDURE
  Undergo bone marrow aspiration and biopsy
• Busulfan — DRUG
  Given IV
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Cyclophosphamide — DRUG
  Given IV
• Dexrazoxane Hydrochloride — DRUG
  Given IV
• Dinutuximab — BIOLOGICAL
  Given IV
• Doxorubicin Hydrochloride — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo echocardiography
• Etoposide Phosphate — DRUG
  Given IV
• External Beam Radiation Therapy — RADIATION
  Undergo EBRT
• Iobenguane I-123 — RADIATION
  Given 123 I-MIBG
• Iobenguane I-131 — RADIATION
  Given IV
• Isotretinoin — DRUG
  Given PO
• Lorlatinib — DRUG
  Given PO
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Melphalan Hydrochloride — DRUG
  Given IV
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA scan
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan
• Sargramostim — BIOLOGICAL
  Given SC
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo standard of care surgery
• Thiotepa — DRUG
  Given IV
• Topotecan Hydrochloride — DRUG
  Given IV
• Vincristine Sulfate — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

May 14, 2018

Status verified

Feb 2026

Primary completion

Sep 30, 2030

Completion

Sep 30, 2030

Study Design

Enrollment

750 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (chemotherapy, HSCT, EBRT)
  See Arm A in detailed description.
• Experimental: Arm B (Iobenguane I-131, chemotherapy, HSCT, EBRT)
  See Arm B in detailed description.
• Experimental: Arm C (Iobenguane I-131, chemotherapy, BuMel, HSCT, EBRT)
  See Arm C in detailed description. Closed to accrual as of 12/17/20.
• Experimental: Arm D (chemotherapy, HSCT, EBRT)
  See Arm D in detailed description.
• Experimental: Arm E (lorlatinib, chemotherapy, HSCT, EBRT)
  See Arm E in detailed description.

Primary Outcome Measure

Event free survival (EFS) (Arm A, B, D, and E) [ Time Frame: 3 years ]

Locations (152)

Find similar trials in Birmingham, AL

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