Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Status: Recruiting
Phase: N/A
DFCI Protocol ID: 00-272

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston, Massachusetts General Hospital

Overall PI:

Suzanne Shusterman, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:


Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria:

  -  All newly diagnosed patients with suspected neuroblastoma, suspected
     ganglioneuroblastoma, or suspected ganglioneuroma/maturing subtype seen at Children's
     Oncology Group (COG) institutions are eligible for this study

       -  There will be no penalty under any circumstances for enrollment of a patient
  whose definitive institutional diagnosis, or central review diagnosis, is found
  to be a tumor other than neuroblastoma, ganglioneuroblastoma, or ganglioneuroma/
  maturing subtype

  -  Patients may not have received chemotherapy prior to enrollment on ANBL00B1 and
     procurement of study-related tissues with the following exception:

       -  Patients that in the opinion of the treating physician are too ill to undergo
  pre-treatment tissue biopsy and require EMERGENT chemotherapy may be enrolled on
  ANBL00B1; documentation of the emergent nature of therapy initiation is required

  -  It is required that a good faith effort (documented by specimen tracking) be made to
     submit a neuroblastoma sample (tumor, metastasis, and/or tumor-involved bone marrow)
     of sufficient quality for MYCN analysis in the Neuroblastoma Reference Laboratory in
     order for any newly diagnosed patient to be enrolled on ANBL00B1; this should be
     obtained prior to initiation of therapy

  -  Exceptions

       -  In rare cases, patients may be deemed too ill to undergo pre-treatment tissue
  biopsy and require EMERGENT therapy; the following eligibility guidelines apply
  to these cases:

    -  For presumed INSS stage 4S patients: Efforts to submit tumor tissue (e.g.,
       primary tumor, skin nodule, or metastatic site) within 96 hours of EMERGENT
       therapy initiation should be made; however, if the child is deemed too
       unstable for such a procedure they may still be enrolled as long as
       pre-treatment peripheral blood and serum have been submitted

    -  For all other INSS stages: tumor tissue should be obtained as soon as
       possible within 96 hours of EMERGENT therapy initiation; patients without
       tumor tissues submitted within this time-frame are not eligible for

 -  Note: it may not be possible to obtain all necessary tumor biomarkers
    for therapy stratification in such cases; if a patient enrolled on
    ANBL00B1 undergoes an additional diagnostic procedure within 96 hours
    of initiating therapy, additional tumor specimens may be submitted to
    obtain biomarkers used for risk classification; the decision to
    perform such procedures, and/or submit these specimens, is to be made
    by the managing clinicians and should reflect the clinical need to
    know the status of such biomarkers

    -  Patients enrolled on ANBL1232 in Group A (either A1 or A2) will not have a
       tumor biopsy or resection upfront; tumor tissue submission is therefore not
       required for these patients to enroll on ANBL00B1; a peripheral blood and
       serum sample is the only specimen required to be submitted for this group
       of patients; should they undergo a biopsy or resection at a later date
       tumor can be submitted for biomarker testing at this time

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

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

Exclusion Criteria:

  -  Patients with relapsed neuroblastoma who were not enrolled on ANBL00B1 at original
     diagnosis are NOT eligible; samples should be submitted as part of the ABTR04B1

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