Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00897663
First received: May 9, 2009
Last updated: July 19, 2016
Last verified: July 2016

May 9, 2009
July 19, 2016
November 2006
January 2100   (final data collection date for primary outcome measure)
Molecular characteristics that predict for overall survival and progression-free survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Molecular characteristics that predict for overall survival and progression-free survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897663 on ClinicalTrials.gov Archive Site
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Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
Optimizing EGFR Inhibitor-Based Therapies for GBM

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with glioblastoma multiforme to identify biomarkers that may improve the selection of patients for epidermal growth factor receptor inhibitor therapies.

OBJECTIVES:

Primary

  • Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with erlotinib hydrochloride, temozolomide, and radiotherapy on clinical trial NCCTG-N0177.

Secondary

  • Identify molecular characteristics that predict for overall survival and progression-free survival of patients treated with gefitinib after radiotherapy on clinical trial NCCTG-N0074.

OUTLINE: This is a multicenter study.

Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Tissue
Probability Sample
Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074.
Brain and Central Nervous System Tumors
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
Single group
Tissue samples from patients enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074 are analyzed by microarray analysis and immunohistochemistry for biological markers predicting progression-free survival and overall survival. Biological markers include epidermal growth factor expression, vIII mutant p53 gene, P-AKT, p7056k, S6, 4EBP1, STAT-3, PLC-g, Erk, ErbB2, ErbB3, ErbB4, platelet-derived growth factor receptor, IGF1R, interleukin-6, FADD, and MGMT.
Interventions:
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: protein expression analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunohistochemistry staining method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
56
Not Provided
January 2100   (final data collection date for primary outcome measure)
All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00897663
N0477, NCCTG-N0477, CDR0000527337, NCI-2009-00645
No
Not Provided
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Jann Sarkaria, MD Mayo Clinic
Alliance for Clinical Trials in Oncology
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP