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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00897663
First received: May 9, 2009
Last updated: July 26, 2013
Last verified: January 2013
  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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Molecular characteristics that predict for overall survival and progression-free survival [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: November 2006
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897663

Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Iowa
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, North Dakota
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
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

No publications provided

ClinicalTrials.gov Identifier: NCT00897663     History of Changes
Other Study ID Numbers: N0477, NCCTG-N0477, CDR0000527337, NCI-2009-00645
Study First Received: May 9, 2009
Last Updated: July 26, 2013
Health Authority: Unspecified

Keywords provided by Alliance for Clinical Trials in Oncology:
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 July 29, 2014