Trials / Completed
CompletedNCT00897663
Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
Optimizing EGFR Inhibitor-Based Therapies for GBM
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 56 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | gene expression analysis | |
| GENETIC | microarray analysis | |
| GENETIC | protein expression analysis | |
| OTHER | diagnostic laboratory biomarker analysis | |
| OTHER | immunohistochemistry staining method |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2009-05-12
- Last updated
- 2018-01-24
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00897663. Inclusion in this directory is not an endorsement.