Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (NCT03126916)
A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or ALK Inhibitor Therapy Added to Intensive Therapy for Children With Newly Diagnosed High-Risk Neuroblastoma (NBL)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Alabama — Birmingham, Alabama
Age range: 365 Days to 30 Years
🧪 Interventions in This Study
- Busulfan (DRUG)
- Carboplatin (DRUG)
- Cisplatin (DRUG)
- Cyclophosphamide (DRUG)
- Dexrazoxane Hydrochloride (DRUG)
- Dinutuximab (BIOLOGICAL)
- Doxorubicin Hydrochloride (DRUG)
- Etoposide Phosphate (DRUG)
- Isotretinoin (DRUG)
- Lorlatinib (DRUG)
- Melphalan Hydrochloride (DRUG)
- Sargramostim (BIOLOGICAL)
- Thiotepa (DRUG)
- Topotecan Hydrochloride (DRUG)
- Vincristine Sulfate (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (164 Sites)
Showing the first 25 of 164 sites.
- Children's Hospital of Alabama — Birmingham, Alabama
- Phoenix Childrens Hospital — Phoenix, Arizona
- Arkansas Children's Hospital — Little Rock, Arkansas
- Kaiser Permanente Downey Medical Center — Downey, California
- Loma Linda University Medical Center — Loma Linda, California
- Children's Hospital Los Angeles — Los Angeles, California
- Mattel Children's Hospital UCLA — Los Angeles, California
- 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
- Rady Children's Hospital - San Diego — San Diego, California
- Naval Medical Center -San Diego — San Diego, California
- UCSF Medical Center-Mission Bay — San Francisco, California
- Children's Hospital Colorado — Aurora, Colorado
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado
- Connecticut Children's Medical Center — Hartford, Connecticut
- Yale University — New Haven, Connecticut
- Alfred I duPont Hospital for Children — Wilmington, Delaware
- Children's National Medical Center — Washington D.C., District of Columbia
- Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida
- UF Health Cancer Institute - Gainesville — Gainesville, Florida
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital — Hollywood, Florida
- Nemours Children's Clinic-Jacksonville — Jacksonville, Florida
📞 Contact the Study Coordinator
Phone: (205) 638-9285
Email: oncologyresearch@peds.uab.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ganglioneuroblastoma
Explore by condition: All Ganglioneuroblastoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.