Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
NCT ID: NCT00897663
Last Updated: 2018-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2006-11-30
2018-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
gene expression analysis
microarray analysis
protein expression analysis
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
Interventions
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gene expression analysis
microarray analysis
protein expression analysis
diagnostic laboratory biomarker analysis
immunohistochemistry staining method
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Jann Sarkaria, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Countries
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Other Identifiers
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NCCTG-N0477
Identifier Type: -
Identifier Source: secondary_id
CDR0000527337
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2009-00645
Identifier Type: REGISTRY
Identifier Source: secondary_id
N0477
Identifier Type: -
Identifier Source: org_study_id
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