Study Information
Summary / Purpose
To determine if the event-free survival of patients with newly diagnosed high-risk neuroblastoma assigned to early chemoimmunotherapy during Induction differs from that of patients who are not assigned to treatment that includes early chemoimmunotherapy.
Study Type: Interventional
Accepts Healthy Volunteers: No
Who Can Participate
Eligibility Criteria: - Children and Adults 0+ years of age
- Patients must be enrolled on APEC14B1 and have consented to testing through the Molecular Characterization Initiative, prior to enrollment on ANBL2131
- Newly diagnosed with high risk neuroblastoma
- Must have a diagnosis of neuroblastoma or ganglioneuroblastoma verified by tumor pathology analysis or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamines
What's Involved
Participation in the study will include: - Bone marrow aspirate/biopsy
- Chemotherapy given intravenously (either cyclophosphamide, topotecan, cisplatin, etoposide, vincristine, and doxorubicin) or chemotherapy plus dinutuximab (chemoimmunotherapy) given intravenously
- Surgery to remove the tumor, followed by stem cell transplant
- Dinutuximab and isotretinoin after transplant to help prevent relapse
- Computed Tomography (CT) scan
- Magnetic Resonance Imaging (MRI) scan
- Metaiodobenzylguanidine (MIBG) scan
- Positron Emission Tomography (PET) scan (if MIBG not suitable)
- Echocardiogram (EKG) to measure heart function
- Blood and urine samples
- Questionnaires
Principal Investigator
Additional Information
Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.
