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Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
NCT02559778 · View on ClinicalTrials.gov ↗
Study Summary
A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma.
Conditions Studied
Interventions
- DRUG DFMO
- DRUG Ceritinib
- DRUG dasatinib
- DRUG sorafenib
- DRUG vorinostat
Study Locations (20)
Florida
- Nicklaus Children's Miami — Miami
- Arnold Palmer Hospital for Children — Orlando
- St. Joseph's Children's Hospital — Tampa
California
- UCSF Benioff Children's Hospital Oakland — Oakland
- Rady Children's Hospital — San Diego
Missouri
- Children's Mercy Hospitals and Clinics — Kansas City
- Cardinal Glennon Children's Medical Center — St Louis
Alabama
- University of Alabama/Children's of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Connecticut
- Connecticut Children's Hospital — Hartford
Georgia
- Augusta University Health — Augusta
Hawaii
- Kapiolani Medical Center for Women and Children — Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2015-09 |
| Est. Completion | 2035-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02559778
The ClinicalTrials.gov registry entry for NCT02559778 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Giselle Sholler, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 5 interventions — of which DFMO is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02559778 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Florida, California, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02559778 about?
NCT02559778 is a clinical study titled "Pediatric Precision Laboratory Advanced Neuroblastoma Therapy". A prospective open label, multicenter study to evaluate the feasibility and acute toxicity of using molecularly guided therapy in combination with standard therapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with ...
What is the current status of trial NCT02559778?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2015-09. Estimated completion is 2035-09.
What conditions does trial NCT02559778 study?
This clinical trial studies the following conditions: Neuroblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02559778?
The interventions under investigation include: DFMO (DRUG), Ceritinib (DRUG), dasatinib (DRUG), sorafenib (DRUG), vorinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02559778?
This trial is sponsored by Giselle Sholler, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02559778 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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