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NCT06172296 · ClinicalTrials.gov registry record · Phase 3
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
A Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, Nodular, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 478
- Enrollment target
- 20
- Study locations
NCT06172296 is a Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, Nodular that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 478 participants, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT06172296, a Phase 3 study of Neuroblastoma and Ganglioneuroblastoma, Nodular, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 478 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Cisplatin
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- City of Hope Comprehensive Cancer Center - Duarte
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Mattel Children's Hospital UCLA - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- Sutter Medical Center Sacramento - Sacramento
- University of California Davis Comprehensive Cancer Center - Sacramento
Arizona
- Banner Children's at Desert - Mesa
- Phoenix Childrens Hospital - Phoenix
- Banner University Medical Center - Tucson - Tucson
Alabama
- Children's Hospital of Alabama - Birmingham
- USA Health Strada Patient Care Center - Mobile
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06172296
The ClinicalTrials.gov registry entry for NCT06172296 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 478 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 94 other Neuroblastoma trials with a reported enrollment target (104% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06172296 reports 20 study locations spanning 4 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06172296 about?
NCT06172296 is a clinical study titled "Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma". 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...
What is the current status of trial NCT06172296?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 478 participants. The study started on 2024-04-19. Estimated completion is 2029-12-31.
What conditions does trial NCT06172296 study?
This clinical trial studies the following conditions: Neuroblastoma, Ganglioneuroblastoma, Nodular.
What interventions are being tested in trial NCT06172296?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cisplatin (DRUG).
Who is sponsoring clinical trial NCT06172296?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06172296 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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