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Studying Tumor Samples From Young Patients With Neuroblastoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00907920
First received: May 22, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

This research study is looking at tumor samples from young patients with neuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer


Condition Intervention
Neuroblastoma
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Observational - Characterizing the Frequency and Spectrum of ALK Mutations in Neuroblastoma

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Event-free survival (EFS) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Using the log rank test, univariate comparisons of EFS and overall survival (OS) will be made for patients with ALK mutations versus those without ALK mutations.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Using the log rank test, univariate comparisons of EFS and OS will be made for patients with ALK mutations versus those without ALK mutations.

  • Disease progression as assessed by International Neuroblastoma Response Criteria [ Time Frame: From the time of diagnosis until the time of first occurrence of relapse, progression, secondary malignancy, or death, or until the time of last contact if no event occurred, assessed up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Correlative studies

Tumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for SNPs by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy).

A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel.

Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients previously enrolled on clinical trial COG-ANBL00B1 Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVE:

I. To comprehensively identify and characterize the spectrum and frequency of mutations in ALK across all neuroblastoma disease subsets using methodologies that will be resource neutral to the Children's Oncology Group Neuroblastoma Nucleic Acids Bank.

SECONDARY OBJECTIVES:

I. To formulate genetic screening recommendations for newly diagnosed patients with or without a family history of neuroblastoma.

II. To identify the functionally relevant ALK mutations that can be pharmacologically inhibited.

III. To test for the prognostic capability of ALK alterations. IV. To determine the clinical significance of ALK mutations and/or genomic rearrangements by combining ALK mutation, amplification, and translocation data overall and within each neuroblastoma risk group and correlating this information with clinical phenotype (i.e., age, International Neuroblastoma Staging System stage, and International Neuroblastoma Pathology Classification); genetic factors (i.e., ploidy, MYCN status); and patient outcome.

OUTLINE:

Tumor DNA samples are examined by mutation analysis for germline and somatic mutations in the ALK tyrosine kinase domain. Samples are analyzed by whole genome amplification using polymerase chain reaction and then sequenced for DNA alterations in the entire ALK coding sequence. Samples are also examined for single nucleotide polymorphisms (SNPs) by polymorphism analysis. Exploratory multivariable analysis is performed to test for the prognostic ability of ALK mutations in the presence of other known prognostic variables (i.e., age, International Neuroblastoma Staging System stage, MYCN status, International Neuroblastoma Pathology Classification, and diploidy).

A subset of tumor DNA samples from high-risk patients will be resequenced for DNA alterations to determine whether or not additional regions in ALK, outside of the tyrosine kinase domain, are prone to mutations and should be sequenced in a larger panel.

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tumor DNA samples available from pediatric patients with newly diagnosed neuroblastoma previously enrolled on clinical trial COG-ANBL00B1
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907920

Locations
United States, California
Children's Oncology Group
Arcadia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Yael Mosse Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00907920     History of Changes
Other Study ID Numbers: ANBL09B1, NCI-2009-00501, COG-ANBL09B1
Study First Received: May 22, 2009
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral

ClinicalTrials.gov processed this record on November 24, 2014