OncoMatch/Clinical Trials/NCT03126916
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Is NCT03126916 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for ganglioneuroblastoma.
Treatment: Busulfan · Carboplatin · Cisplatin · Cyclophosphamide · Dexrazoxane Hydrochloride · Dinutuximab · Doxorubicin Hydrochloride · Etoposide Phosphate · Isotretinoin · Lorlatinib · Melphalan Hydrochloride · Sargramostim · Thiotepa · Topotecan Hydrochloride · Vincristine Sulfate — This phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Biomarker criteria
Required: ALK aberration
Required: MYCN amplification (> 4-fold increase in mycn signals as compared to reference signals)
Disease stage
Required: Stage INRG STAGE M, INRG STAGE MS, INRG STAGE L2, INRG STAGE L1 (INRG)
Excluded: Stage INRG STAGE L2 TUMORS WITHOUT AMPLIFICATION OF MYCN
Patients with International Neuroblastoma Risk Group (INRG) stage M disease... Patients with INRG stage MS disease with MYCN amplification... Patients with INRG stage L2 disease with MYCN amplification... Patients > 547 days of age initially diagnosed with INRG stage L1, L2 or MS disease who progressed to stage M... Patients >= 365 days of age initially diagnosed with MYCN amplified INRG stage L1 disease who progress to stage M...
Prior therapy
Cannot have received: ALK inhibitor (lorlatinib)
Patients who have previously received treatment with lorlatinib or other ALK inhibitor
Lab requirements
Kidney function
Creatinine clearance or radioisotope GFR >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex
Liver function
Total bilirubin <= 1.5 x upper limit of normal (ULN) for age; SGPT (ALT) < 10 x ULN (ULN for SGPT (ALT) is 45)
Cardiac function
Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/sex as follows... Total bilirubin <= 1.5 x upper limit of normal (ULN) for age... SGPT (ALT) < 10 x ULN... Shortening fraction of >= 27% by echocardiogram, or ejection fraction of > 50% by echocardiogram or radionuclide angiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Valley Children's Hospital · Madera, California
- Kaiser Permanente-Oakland · Oakland, California
- Children's Hospital of Orange County · Orange, California
- Lucile Packard Children's Hospital Stanford University · Palo Alto, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify