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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:
ClinicalTrials.gov Identifier:
NCT00897663
First Posted: May 12, 2009
Last Update Posted: July 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
May 9, 2009
May 12, 2009
July 20, 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 ]
Molecular characteristics that predict for overall survival and progression-free survival
Complete list of historical versions of study NCT00897663 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.
Sexes Eligible for Study: All
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 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00645 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
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