A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma
Giselle Sholler
Summary
A 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 Subjects with Newly Diagnosed High-Risk Neuroblastoma.
Eligibility
- Age range
- Up to 22 years
- Sex
- All
- Healthy volunteers
- No
Part A- CLOSED: 1. Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria: a) Subjects with newly diagnosed neuroblastoma with INSS Stage 4 are eligible with the following: i. Age \> 18 months (\> 547 days) regardless of biologic features or ii. Age 12-18 months (365-547 days) with any of the following…