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NCT03794349 · ClinicalTrials.gov registry record · Phase 2
Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma
A Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 20
- Study locations
NCT03794349 is a Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 94 participants, above the 55-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (71% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT03794349, a Phase 2 study of High-risk Neuroblastoma and Refractory Neuroblastoma, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydrochloride 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. 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. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving eflornithine with irinotecan hydrochloride, temozolomide, and dinutuximab, may work better in treating patients with relapsed or refractory neuroblastoma.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan Hydrochloride
- BIOLOGICAL Sargramostim
- BIOLOGICAL Dinutuximab
- DRUG Eflornithine Hydrochloride
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- Valley Children's Hospital - Madera
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- University of California Davis Comprehensive Cancer Center - Sacramento
- Rady Children's Hospital - San Diego - San Diego
- UCSF Medical Center-Mission Bay - San Francisco
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Connecticut
- Connecticut Children's Medical Center - Hartford
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- Children's National Medical Center - Washington D.C.
Alabama
- Children's Hospital of Alabama - Birmingham
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2029-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03794349
The ClinicalTrials.gov registry entry for NCT03794349 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 55-participant average among 9 other High-risk Neuroblastoma trials with a reported enrollment target (71% higher). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with High-risk Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Temozolomide is the first listed.
NCT03794349 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03794349 about?
NCT03794349 is a clinical study titled "Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma". This phase II trial studies how well irinotecan hydrochloride, temozolomide, and dinutuximab work with or without eflornithine in treating patients with neuroblastoma that has come back (relapsed) or that isn't responding to treatment (refractory). Drugs used in chemotherapy, such as irinotecan hydr...
What is the current status of trial NCT03794349?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-07-08. Estimated completion is 2029-03-31.
What conditions does trial NCT03794349 study?
This clinical trial studies the following conditions: High-risk Neuroblastoma, Refractory Neuroblastoma, Recurrent Neuroblastoma.
What interventions are being tested in trial NCT03794349?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan Hydrochloride (DRUG), Sargramostim (BIOLOGICAL), Dinutuximab (BIOLOGICAL), Eflornithine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03794349?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03794349 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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