Viewing Study NCT02868268



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Last Modification Date: 2024-10-26 @ 12:07 PM
Study NCT ID: NCT02868268
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-02-09
First Post: 2016-06-03

Brief Title: Neuroblastoma Precision Trial
Sponsor: New Approaches to Neuroblastoma Therapy Consortium
Organization: New Approaches to Neuroblastoma Therapy Consortium

Study Overview

Official Title: N2015-01 Neuroblastoma Precision Trial
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This proposal sets forth the platform for a Precision Medicine clinical trial through the New Approaches to Neuroblastoma Therapy NANT consortium The plan is to utilize NANTs established multi-institutional infrastructure and Translational Genomics Research Institute GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological specimens in relapsedrefractory neuroblastoma rNB including those obtained from the bone bone marrow or soft tissue Our primary aim is to identify subgroups of rNB patients who have potentially targetable genetic ALK MAPK pathway Metabolic-related genes andor immunologic tumor-associated macrophage infiltration andor programmed death ligand PD-L1 expression biomarkers in rNB Additional potential novel biomarkers will also be evaluated and reported in this cohort of patients
Detailed Description: Neuroblastoma NB is the most common extracranial solid tumor of childhood High-risk NB is highly lethal and responsible for over 15 of childhood cancer related deaths The majority of patients with metastatic NB respond to upfront cytotoxic chemotherapy yet patients who die of recurrent disease do so from tumor acquired resistance to treatment Thus understanding the repertoire of tumor specific genomic alterations leading to tumor progression and therapy resistance is critical to devising novel targeted therapy options for patients with recurrent or refractory rNB Limited data exists regarding the genetic and immunologic predictive biomarkers in rNB which can be used to direct targeted therapies Another barrier to clinical implementation of genetic testing of tumor samples from children with rNB is obtaining sufficient number of tumor cells from bone marrow BM specimens the most easily accessible and common site of relapse This proposal sets forth the platform for a Precision Medicine clinical trial through the New Approaches to Neuroblastoma Therapy NANT consortium The plan is to utilize NANTs established multi-institutional infrastructure and Translational Genomics Research Institute TGen GEMTM sequencing platform for acquisition and gene panel sequencing of relapsed biological specimens in rNB including those obtained from the bone bone marrow or soft tissue Our primary aim is to identify subgroups of rNB patients who have potentially targetable genetic ALK MAPK pathway Metabolic-related genes andor immunologic tumor-associated macrophage infiltration andor PD-L1 expression biomarkers in rNB Additional potential novel biomarkers will also be evaluated and reported in this cohort of patients This aim has immediate impact on the lives of children with rNB as it provides a clinical report to patients and their physicians detailing observed mutations and rNB subgroups and information on clinical trials that best match them Our second aim will assess a novel method for enriching tumor cells from bone marrow aspirates containing less than 30 tumor involvement so that next generation sequencing can be performed Our bone marrow BM enrichment protocol has both methodological and patient significance 1 BM enrichment will allow a much larger group of rNB patients access to future personalized medicine trials and 2 Successful confirmation that BM enrichment can produce quality DNA for genetic analysis serves as proof of principal that this method can be used for genetic testing of BM with evidence of metastasis in other adult or pediatric solid tumors In summary our proposal will define the genetic and immunologic landscape of rNB and contribute to our understanding and ability to therapeutically target the dynamic alterations in tumor biology of children with rNB

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
N2015-01 OTHER NANT Consortium None