Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma

Conditions

• Ganglioneuroblastoma, Nodular
• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

N/A - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood and urine sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Bone Marrow Biopsy — PROCEDURE
  Undergo bone marrow biopsy
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Cyclophosphamide — DRUG
  Given IV
• Dinutuximab — BIOLOGICAL
  Given IV
• Doxorubicin — DRUG
  Given IV
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• Etoposide — DRUG
  Given IV
• FDG-Positron Emission Tomography and Computed Tomography Scan — PROCEDURE
  Undergo FDG PET
• Hematopoietic Cell Transplantation — PROCEDURE
  Undergo stem cell infusion
• Irinotecan — DRUG
  Given IV
• Isotretinoin — DRUG
  Given PO
• Leukapheresis — PROCEDURE
  Undergo apheresis
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Melphalan — DRUG
  Given IV
• Multigated Acquisition Scan — PROCEDURE
  Undergo MUGA
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Radionuclide Imaging — PROCEDURE
  Undergo I-MIBG scan
• Survey Administration — OTHER
  Ancillary studies
• Temozolomide — DRUG
  Given PO or via NG or G tube
• Thiotepa — DRUG
  Given IV
• Topotecan — DRUG
  Given IV
• Tumor Resection — PROCEDURE
  Undergo tumor resection surgery
• Vincristine — DRUG
  Given IV

Study Details

This phase III trial tests how well the addition of dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy works for treating children with newly diagnosed high-risk neuroblastoma. Dinutuximab is a monoclonal antibody that binds to a molecule called GD2, which is found on the surface of neuroblastoma cells, but is not present on many healthy or normal cells in the body. When dinutuximab binds to the neuroblastoma cells, it helps signal the immune system to kill the tumor cells. This helps the cells of the immune system kill the cancer cells, this is a type of immunotherapy. When chemotherapy and immunotherapy are given together, during the same treatment cycle, it is called chemoimmunotherapy. This clinical trial randomly assigns patients to receive either standard chemotherapy and surgery or chemoimmunotherapy (chemotherapy plus dinutuximab) and surgery during Induction therapy. Chemotherapy drugs administered during Induction include, cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin. These drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Upon completion of 5 cycles of Induction therapy, a disease evaluation is completed to determine how well the treatment worked. If the tumor responds to therapy, patients receive a tandem transplantation with stem cell rescue. If the tumor has little improvement or worsens, patients receive chemoimmunotherapy on Extended Induction. During Extended Induction, dinutuximab is given with irinotecan, temozolomide. Patients with a good response to therapy move on to Consolidation therapy, when very high doses of chemotherapy are given at two separate points to kill any remaining cancer cells. Following, transplant, radiation therapy is given to the site where the cancer originated (primary site) and to any other areas that are still active at the end of Induction. The final stage of therapy is Post-Consolidation. During Post-Consolidation, dinutuximab is given with isotretinoin, with the goal of maintaining the response achieved with the previous therapy. Adding dinutuximab to Induction chemotherapy along with standard of care surgical resection of the primary tumor, radiation, stem cell transplantation, and immunotherapy may be better at treating children with newly diagnosed high-risk neuroblastoma.

Key Dates

Start date

Apr 19, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2029

Study Design

Enrollment

478 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (SOC treatment)
  See detailed description
• Experimental: Arm B (Dinutuximab in induction)
  See detailed description

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: Up to 3 years ]

Locations (156)

Find similar trials in Birmingham, AL

Related Studies

• Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York
• Molecular Characterization of Neuroblastic Tumor: Correlation With Clinical Outcome
  Recruiting · Memorial Sloan Kettering Cancer Center · New York, New York
• Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
  Recruiting · National Cancer Institute (NCI) · Washington D.C., District of Columbia