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NCT04385277 · ClinicalTrials.gov registry record · Phase 2
Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)
A Phase 2 study of Neuroblastoma and Ganglioneuroblastoma, Nodular, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 20
- Study locations
NCT04385277: Active Phase 2 study of Neuroblastoma and Ganglioneuroblastoma, Nodular, sponsored by Children's Oncology Group.
NCT04385277 is a Phase 2 study of Neuroblastoma and Ganglioneuroblastoma, Nodular that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 41 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04385277, a Phase 2 study of Neuroblastoma and Ganglioneuroblastoma, Nodular, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiation) who have not experienced worsening or recurrence of their disease. Dinutuximab represents a kind of cancer therapy called immunotherapy. Unlike chemotherapy and radiation, dinutuximab targets the cancer cells without destroying nearby healthy cells. Sargramostim helps the body produce normal infection-fighting white blood cells. Isotretinoin helps the neuroblastoma cells become more mature. These 3 drugs (standard immunotherapy) are already given to patients with high-risk neuroblastoma after Consolidation because they have been proven to be beneficial in this setting. Chemotherapy drugs, such as irinotecan and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. They may also affect how well immunotherapy works on neuroblastoma cells. Giving chemo-immunotherapy after intensive therapy may work better in treating patients with high-risk neuroblastoma compared to standard immunotherapy.
Primary Outcome
Will be assessed by estimation of the feasibility therapy completion rate together with a 95% Wilson confidence interval (CI).
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- BIOLOGICAL Dinutuximab
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Children's Hospital Los Angeles - Los Angeles
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- UCSF Medical Center-Mission Bay - San Francisco
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- University of Florida Health Science Center - Gainesville - Gainesville
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
- Nemours Children's Clinic-Jacksonville - Jacksonville
- Nemours Children's Hospital - Orlando
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Arizona
- Banner Children's at Desert - Mesa
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2020-12-31 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 2 |
What the registry record for NCT04385277 still lists
NCT04385277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (83% lower).
The record links to 2 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04385277 names 20 study sites across 11 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT04385277 about?
NCT04385277 is a clinical study titled "Treatment With Dinutuximab, Sargramostim (GM-CSF), and Isotretinoin in Combination With Irinotecan and Temozolomide After Intensive Therapy for People With High-Risk Neuroblastoma (NBL)". This phase II trial studies if dinutuximab, GM-CSF, isotretinoin in combination with irinotecan, and temozolomide (chemo-immunotherapy) can be given safely to patients with high-risk neuroblastoma after Consolidation therapy (which usually consists of two autologous stem cell transplants and radiati...
What is the current status of trial NCT04385277?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2020-12-31. Estimated completion is 2027-09-30.
What conditions does trial NCT04385277 study?
This clinical trial studies the following conditions: Neuroblastoma, Ganglioneuroblastoma, Nodular.
What interventions are being tested in trial NCT04385277?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04385277?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04385277 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04385277's enrollment target sits among peer trials
41 50th of 94 higher than 44 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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