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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.

Phase 2RecruitingGiselle ShollerNCT02559778Data as of May 2026

Treatment: Ceritinib · dasatinib · sorafenib · vorinostat · DFMOA 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.

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Extracted 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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