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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

All patients entered onto N0177 and N0074 who have appropriate archived clinical specimens.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00897663
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alliance for Clinical Trials in Oncology
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jann Sarkaria, MD
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

: 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Scottsdale, Scottsdale, Arizona

Status

Address

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499

Mayo Clinic - Jacksonville, Jacksonville, Florida

Status

Address

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224

Sioux City, Iowa

Status

Address

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101

Mercy Medical Center - Sioux City, Sioux City, Iowa

Status

Address

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51102

St. Luke's Regional Medical Center, Sioux City, Iowa

Status

Address

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104

Mayo Clinic Cancer Center, Rochester, Minnesota

Status

Address

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905

Bismarck, North Dakota

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Address

Medcenter One Hospital Cancer Care Center

Bismarck, North Dakota, 58501

Mid Dakota Clinic, PC, Bismarck, North Dakota

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Address

Mid Dakota Clinic, PC

Bismarck, North Dakota, 58501

St. Alexius Medical Center Cancer Center, Bismarck, North Dakota

Status

Address

St. Alexius Medical Center Cancer Center

Bismarck, North Dakota, 58502

Rapid City Regional Hospital, Rapid City, South Dakota

Status

Address

Rapid City Regional Hospital

Rapid City, South Dakota, 57701