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OncoMatch/Clinical Trials/NCT02559778

Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

Is NCT02559778 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments for neuroblastoma.

Phase 2RecruitingGiselle ShollerNCT02559778Data as of Sep 2026Location: United States · Canada

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 Newly Diagnosed High-Risk Neuroblastoma.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Ceritinibdasatinibsorafenibvorinostat

Other

DFMO

Cancer type

Neuroblastoma

Biomarker criteria

Required: MYCN amplification

MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals)

Excluded: MYCN nonamplified

nonamplified MYCN (exclusion for certain age/stage/biologic feature combinations)

Disease stage

Required: Stage INSS STAGE 4, INSS STAGE 3, INSS STAGE 2A, INSS STAGE 2B (other)

Participants with the following disease stages at diagnosis are eligible: INSS Stage 4, INSS Stage 3, INSS Stage 2A/2B (with additional criteria)

Demographics

Ages ≤ 22

Prior therapy

Max 1 prior line

Lab requirements

Kidney function

eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz equation for <17 years, Cockcroft and Gault for ≥17 years)

Liver function

Total bilirubin ≤ 1.5 x ULN for age AND ALT (SGPT) < 10 x ULN for age

Cardiac function

Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram

Adequate Cardiac Function: Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide evaluation or echocardiogram. Adequate liver function: Total bilirubin ≤ 1.5 x ULN for age AND ALT (SGPT) < 10 x ULN for age. Renal: eGFR ≥ 70 mL/min/1.73 m2 (Bedside Schwartz equation for <17 years, Cockcroft and Gault for ≥17 years)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama/Children's of Alabama · Birmingham, Alabama
  • Arkansas Children's Hospital · Little Rock, Arkansas
  • UCSF Benioff Children's Hospital Oakland · Oakland, California
  • Rady Children's Hospital · San Diego, California
  • Connecticut Children's Hospital · Hartford, Connecticut

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT02559778 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require MYCN?

Yes, MYCN amplification is a required biomarker for enrollment.

Are patients with MYCN alterations eligible?

No. MYCN nonamplified is an exclusion criterion.

What disease stage is eligible?

Stage INSS STAGE 4 or INSS STAGE 3 or INSS STAGE 2A or INSS STAGE 2B is required.

Is there an age limit?

Yes. Patients must be 22 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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