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NCT03786783 · ClinicalTrials.gov registry record · Phase 2
Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
A Phase 2 study of High-risk Neuroblastoma and Ganglioneuroblastoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 10
- Study locations
NCT03786783: Active Phase 2 study of High-risk Neuroblastoma and Ganglioneuroblastoma, sponsored by National Cancer Institute (NCI).
NCT03786783 is a Phase 2 study of High-risk Neuroblastoma and Ganglioneuroblastoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 61-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (31% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03786783, a Phase 2 study of High-risk Neuroblastoma and Ganglioneuroblastoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 10
- Study locations
Study Summary
This phase II pilot trial studies the side effects and how well dinutuximab and sargramostim work when combined with chemotherapy in patients with high-risk neuroblastoma. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Sargramostim helps the body produce normal infection-fighting white blood cells. These cells also help the dinutuximab work better. Giving chemotherapy before a stem cell transplant, with drugs such as cisplatin, etoposide, vincristine, doxorubicin, cyclophosphamide, thiotepa, melphalan, etoposide, carboplatin, topotecan, and isotretinoin, helps kill cancer cells that are in the body and helps make room in a patient's bone marrow for new blood-forming cells (stem cells). Giving dinutuximab and sargramostim with combination chemotherapy may work better than combination chemotherapy alone in treating patients with high-risk neuroblastoma.
Primary Outcome
Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Assessed by estimation of the combined toxic death and unacceptable toxicity rate during Induction cycles 3-5 together with a 95% confidence interval.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Cisplatin
- PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
- DRUG Dexrazoxane
Study Locations (10)
California
- Children's Hospital Los Angeles - Los Angeles
District of Columbia
- Children's National Medical Center - Washington D.C.
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Tennessee
- Saint Jude Children's Research Hospital - Memphis
Utah
- Primary Children's Hospital - Salt Lake City
New South Wales
- The Children's Hospital at Westmead - Westmead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2026-09-19 |
| Phase | Phase 2 |
What the registry record for NCT03786783 still lists
NCT03786783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 61-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (31% lower).
The record links to 2 conditions, with High-risk Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03786783 lists 10 locations in 10 states (California, District of Columbia, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT03786783 about?
NCT03786783 is a clinical study titled "Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma". This phase II pilot trial studies the side effects and how well dinutuximab and sargramostim work when combined with chemotherapy in patients with high-risk neuroblastoma. Immunotherapy with monoclonal antibodies, such as dinutuximab, may induce changes in the body's immune system and may interfere ...
What is the current status of trial NCT03786783?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-03-04. Estimated completion is 2026-09-19.
What conditions does trial NCT03786783 study?
This clinical trial studies the following conditions: High-risk Neuroblastoma, Ganglioneuroblastoma.
What interventions are being tested in trial NCT03786783?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Cisplatin (DRUG), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Dexrazoxane (DRUG).
Who is sponsoring clinical trial NCT03786783?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03786783 being conducted?
This trial has 10 study locations across California, District of Columbia, Massachusetts, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High-risk Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03786783's enrollment target sits among peer trials
42 8th of 9 higher than 1 of 9 other High-risk Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High-risk Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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