OncoMatch/Clinical Trials/NCT02559778
Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
Is NCT02559778 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for neuroblastoma.
Treatment: Ceritinib · dasatinib · sorafenib · vorinostat · DFMO — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Required: MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)
MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)
Disease stage
Required: Stage 2A, 2B, III, IV
Prior therapy
Cannot have received: systemic therapy
Exception: localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology
Subjects must not have had prior systemic therapy except for localized emergency radiation to sites of life-threatening or function-threatening disease and/or no more than 1 cycle of chemotherapy per a low or intermediate risk neuroblastoma regimen (as per P9641, A3961, ANBL0531, or similar) prior to determination of MYCN amplification status and histology
Lab requirements
Kidney function
Serum creatinine based on age/gender as specified in protocol table
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND ALT (SGPT) < 10 x upper limit of normal (ULN) for age
Cardiac function
Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram
Adequate Cardiac Function Defined As: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram. Adequate liver function must be demonstrated, defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND ALT (SGPT) < 10 x upper limit of normal (ULN) for age. Subjects must have adequate renal function defined as a serum creatinine based on age/gender as specified in protocol table.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Lukes · Boise, Idaho
- Advocate Aurora Research Institute · Chicago, Illinois
- Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine · Louisville, Kentucky
- Helen DeVos Children's Hospital · Grand Rapids, Michigan
- Children's Hospital and Clinics of Minnesota · Minneapolis, Minnesota
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