©2024 Stanford Medicine
Neuroblastoma Precision Trial
Not Recruiting
Trial ID: NCT02868268
Purpose
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 NANT's
established multi-institutional infrastructure and Translational Genomics Research Institute
GEM sequencing platform for acquisition and gene panel sequencing of relapsed biological
specimens in relapsed/refractory 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) and/or
immunologic (tumor-associated macrophage infiltration and/or programmed death ligand [PD-L1]
expression) biomarkers in rNB. Additional potential novel biomarkers will also be evaluated
and reported in this cohort of patients.
Official Title
N2015-01: Neuroblastoma Precision Trial
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Patients must be ≥ 1 year and ≤ 30 years of age at study registration
- Patients must have had a diagnosis of neuroblastoma either by histological
verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow
with increased urinary catecholamines.
- Patients must have a history of high-risk neuroblastoma according to
- COG risk classification at the time of study registration. Patients must have at least
one of the following: Recurrent/progressive disease, Refractory disease, Persistent
disease
- Patient must be willing to undergo a clinically indicated biopsy and meet at least one
of the following requirements: Bone biopsy, Soft tissue biopsy, Bone marrow biopsy and
aspirate
- Patients must not be receiving any other anti-cancer agents or radiotherapy during the
interval
Exclusion Criteria:
- Patients with disease of any major organ system that would compromise their ability to
withstand biopsy procedures of soft tissue, bone and/or bone marrow.
- Patients who enroll and successfully receive a NANT Precision Report may not re-enroll
at a future time.
- Patient declines participation in NANT 2004-05, the NANT Biology Study.
Intervention(s):
other: Gene panel sequencing of tumor specimens
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-499-7061