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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Response and Biology-Based Risk Factor-Guided Therapy in Treating Younger Patients with Non-high Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.
Neuroblastoma (Pediatrics)
Phase III
Children
Supportive Care, Therapy (NOS)
Not Available
Pastakia, Devang
National
Vanderbilt University
08-20-2014
Utilizing Resp-and Biology-Based Risk Factors Thx in Pts w/ Non-High-Risk Neuroblastoma
Treatment
COGANBL1232
NCT02176967

Eligibility

0 Months
BOTH
NO
Inclusion Criteria:

Patients must be: *
Enrollment on ANBL00B1 or APEC14B1 is required for all newly diagnosed patients

Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology 9500/3) or MYCN non-amplified ganglioneuroblastoma verified by histology

Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) and deoxyribonucleic acid (DNA) index * “Favorable” genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > 1) in the absence of segmental chromosome aberrations as defined above * “Unfavorable” genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at 1p, 3p, 4p, or 11q or somatic copy number gain at 1q, 2p, or 17q) or diploid tumor (DNA index = 1); this includes copy neutral loss of heterozygosity (LOH) * Only patients with MYCN non-amplified tumors are eligible for this study

Group A: patients
Group A will be further split into two subsets, which are mutually exclusive, for statistical purposes * Group A1: ** > 6 months and 3.1 and
Group B: patients
Group C: patients
No prior radiotherapy or chemotherapy, with the exception of dexamethasone, which is allowed

All patients and/or their parents or legal guardians must sign a written informed consent

All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met



Exclusion Criteria:

Patients with MYCN amplified tumors are not eligible

Group B and C patients who do not enroll on ANBL1232 within 4 weeks of definitive diagnostic procedure

Group A and C patients, not required to undergo tumor biopsy, who do not enroll on ANBL1232 within 4 weeks of confirmatory imaging study

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