Lorlatinib + Standard Therapy for Neuroblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Iobenguane I-131, Lorlatinib, Lorbrena for neuroblastoma?
Is the combination of Lorlatinib and Iobenguane I-131 safe for treating neuroblastoma?
Lorlatinib has been studied for safety in children and adults with neuroblastoma, showing common side effects like high triglycerides, high cholesterol, and weight gain, with some neurobehavioral effects in adults that improved with dose adjustments. Iobenguane I-131 is considered a safe treatment for neuroblastoma, used in various studies for high-risk cases.12678
How does the drug lorlatinib differ from other treatments for neuroblastoma?
Lorlatinib is unique because it is a third-generation ALK inhibitor specifically effective against ALK-driven neuroblastoma that is resistant to other treatments like crizotinib. It can be used alone or in combination with chemotherapy, showing promising response rates in both children and adults with relapsed or refractory neuroblastoma.467910
What is the purpose of this trial?
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.
Research Team
Steven DuBois
Principal Investigator
Children's Oncology Group
Eligibility Criteria
This trial is for young patients up to 30 years old with high-risk neuroblastoma or ganglioneuroblastoma. They must have certain levels of kidney and liver function, no prior systemic therapy (with some exceptions), and can't be pregnant or breastfeeding. Patients need a confirmed diagnosis and meet specific criteria based on their disease stage and features.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Therapy
Patients receive cyclophosphamide, topotecan hydrochloride, and other chemotherapy agents as part of induction therapy
Consolidation Therapy
Patients undergo high-dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT)
Post-Consolidation Therapy
Patients receive sargramostim, dinutuximab, isotretinoin, and possibly lorlatinib
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Iobenguane I-131
- Lorlatinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator