Improving the Selection of Patients With Glioblastoma Multiforme for Treatment With Epidermal Growth Factor Receptor Inhibitor Therapies
This study is currently recruiting participants.
Verified January 2013 by National Cancer Institute (NCI)
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897663
First received: May 9, 2009
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
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 |
| Study Type: | Observational |
| Official Title: | Optimizing EGFR Inhibitor-Based Therapies for GBM |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Molecular characteristics that predict for overall survival and progression-free survival [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | November 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Enrolled on clinical trials NCCTG-N0177 or NCCTG-N0074
- Must have appropriate archived clinical specimens
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897663
Locations
| United States, Arizona | |
| Mayo Clinic Scottsdale | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Florida | |
| Mayo Clinic - Jacksonville | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Iowa | |
| Mercy Medical Center - Sioux City | Recruiting |
| Sioux City, Iowa, United States, 51102 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| Siouxland Hematology-Oncology Associates, LLP | Recruiting |
| Sioux City, Iowa, United States, 51101 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| St. Luke's Regional Medical Center | Recruiting |
| Sioux City, Iowa, United States, 51104 | |
| Contact: Donald B. Wender, MD, PhD 712-252-0088 | |
| United States, Minnesota | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, North Dakota | |
| Medcenter One Hospital Cancer Care Center | Recruiting |
| Bismarck, North Dakota, United States, 58501 | |
| Contact: John T. Reynolds 701-323-5741 | |
| Mid Dakota Clinic, PC | Recruiting |
| Bismarck, North Dakota, United States, 58501 | |
| Contact: Clinical Trials Office - Mid Dakota Clinic, PC 701-530-6950 | |
| St. Alexius Medical Center Cancer Center | Recruiting |
| Bismarck, North Dakota, United States, 58502 | |
| Contact: Clinical Trials Office - St. Alexius Medical Center Cancer Cen 701-530-6950 | |
| United States, South Dakota | |
| Rapid City Regional Hospital | Recruiting |
| Rapid City, South Dakota, United States, 57701 | |
| Contact: Richard C. Tenglin 605-719-2360 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Study Chair: | Jann N. Sarkaria, MD | Mayo Clinic |
| Investigator: | Paul D. Brown, MD | Mayo Clinic |
| Investigator: | Joon H. Uhm, MD | Mayo Clinic |
| Investigator: | Jan C. Buckner, MD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897663 History of Changes |
| Other Study ID Numbers: | CDR0000527337, NCCTG-N0477 |
| Study First Received: | May 9, 2009 |
| Last Updated: | January 16, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adult giant cell glioblastoma adult gliosarcoma adult glioblastoma |
Additional relevant MeSH terms:
|
Glioblastoma Nervous System Neoplasms Central Nervous System Neoplasms Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases |
ClinicalTrials.gov processed this record on June 17, 2013