A Prospective National Study to Molecularly and Genetically Characterize Human Gliomas: The Glioma Molecular Diagnostic Initiative
Protocol # 02-C-0140
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the treatment plan?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Primary brain tumors are an increasingly important cause of cancer-related morbidity and mortality in this country. Little progress has been made in the treatment of patients with gliomas over the last decade. One of the largest problems in our understanding, and ultimately in our successful treatment of gliomas, is the great heterogeneity between tumors.
The purpose of this study is to generate a large publicly accessible molecular and genetic database with prospective corollary clinical data for 1000 gliomas for the purpose of allowing investigators from around the world to ask important questions regarding the pathogenesis of these tumors, the development of novel molecular classification schemas, and the identification of potentially new and important therapeutic targets.
Who is eligible for this trial?
- Patients with radiographic suggestion of a primary glial neoplasm or known glial neoplasm
- Patients with plans to undergo a medically indicated (diagnostic and/or therapeutic) tumor resection or biopsy
What types of drugs or therapies are being used?
Patients will undergo medically indicated (diagnostic and/or therapeutic) tumor resection, or biopsy.
What is the treatment plan?
- Samples of tumor tissue will be removed as part of normal care and 10 mL of blood will be taken for genetic analysis
- Patients will be evaluated every 6 months with a physical/neurological examination and with either an MRI (preferably) or a CT scan
What is the frequency and duration of the visits?
Patients will return every 6 months to the NIH.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Howard A. Fine is currently chief of the Neuro-Oncology Branch at NCI's Center for Cancer Research, and of the National Institute of Neurologic Disorders and Stroke. He received his B.A. from the University of Pennsylvania, Philadelphia, and his M.D. from Mount Sinai School of Medicine, New York. Dr. Fine completed both his internship and his residency in internal medicine at the Hospital of The University of Pennsylvania. Three years later he completed his fellowship in medical oncology at Harvard Medical School's Dana-Farber Cancer Institute, Boston, Mass. Before joining the NIH in 2000, Dr. Fine was both director of the Neuro-Oncology Disease Center at the Dana-Farber Cancer Institute, and of the Neuro-Oncology Program at the Harvard Cancer Center. This NCI senior investigator serves on several committees, including the Brain Tumor Program Review Group and the American Joint Committee on Cancer. Dr. Fine also serves on the editorial boards of several journals, including the Journal of Clinical Oncology, Neuro-Oncology, and The Oncologist. He has received several distinguished awards, including the Dana-Farber Harvard Cancer Center's Clinical Investigator Award in 1999, the Emil Frei III Clinical Investigator Award in 1993, and the Brain Tumor Society Research Award in 1992. His research interests include tumor angiogenesis, therapeutic gene transfer, and neural stem cell biology.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Neuro-Oncology
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Howard A. Fine, M.D.
Principal Investigator
Phone: 301-402-6298
Referrals:
Charisse Garcia, R.N.
Research Nurse
Phone: 301-402-6298
Fax: 301-480-2246
Toll free: 866-251-9686
garciacr@mail.nih.gov
Julie Peretti, R.N.
Research Nurse
Phone: 301-402-6298
Fax: 301-480-2246
Toll free: 866-251-9686
jperetti@mail.nih.gov
Tracy Cropper, R.N.
Research Nurse
Phone: 301-496-8250
Fax: 301-480-2246
Toll free: 866-251-9686
tcropper@mail.nih.gov
Where can additional information be found?
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