- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001171
Evaluation of Factors in Human Brain Tumors
Evaluation of Biological, Immunological and Therapeutic Parameters in Brain Tumor Patients
Presently, patients with primary malignant brain tumors have a life expectancy of 15 weeks following surgery unless they receive additional types of therapy (chemotherapy, radiotherapy, and/or immunotherapy). Patients that receive additional therapy can increase life expectancy to 50 weeks.
The statistics on the life expectancy and survival have increased efforts among researchers to develop new treatments for primary malignant brain tumors.
This research project involves the growth and study of human brain tumor cells outside the body in the laboratory as part of an attempt to better understand these tumors and to develop more effective treatments for them.
Study Overview
Status
Conditions
Detailed Description
This protocol involves the study of human brain tumor cells outside the body in the laboratory as part of an attempt to better understand these tumors and to develop more effective therapeutic measures.
Malignant primary brain tumor patients at present have a life expectancy of approximately 15 weeks following surgery unless other adjunctive measures are taken. With currently available adjunctive therapy the life expectancy reaches 50 weeks.
These survival data have spurred extensive efforts to develop new treatment modalities. Radiation, chemotherapy and immunotherapy have been mildly helpful adjuncts but their use has been largely on empirical grounds or on the basis of experimentation on animal tumor models often quite different in nature from human brain tumors.
Our group has sought to develop data upon which to devise new treatment strategies for patients with malignant brain tumors.
The foundation of our approach rests upon the use of in vitro studies of the cell biology of each patient's tumor.
It is our plan to utilize these tumors for in vitro investigation of the immunology, biology, biochemistry and molecular biology of brain tumors. Optimal conventional therapy will be given to the patients as we seek to learn more of how the scientific information obtained can be used to help them.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Patients to be studied will have either undergone surgical confirmation of a malignant primary brain tumor or be considered likely to have that diagnosis on the basis of diagnostic studies.
They should have survival likelihood of at least three months and be able to comprehend the nature of the proposed program.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Manski TJ, Heffner DK, Glenn GM, Patronas NJ, Pikus AT, Katz D, Lebovics R, Sledjeski K, Choyke PL, Zbar B, Linehan WM, Oldfield EH. Endolymphatic sac tumors. A source of morbid hearing loss in von Hippel-Lindau disease. JAMA. 1997 May 14;277(18):1461-6. doi: 10.1001/jama.277.18.1461.
- Mason RB, Nieman LK, Doppman JL, Oldfield EH. Selective excision of adenomas originating in or extending into the pituitary stalk with preservation of pituitary function. J Neurosurg. 1997 Sep;87(3):343-51. doi: 10.3171/jns.1997.87.3.0343.
- Zunkeler B, Carson RE, Olson J, Blasberg RG, Girton M, Bacher J, Herscovitch P, Oldfield EH. Hyperosmolar blood-brain barrier disruption in baboons: an in vivo study using positron emission tomography and rubidium-82. J Neurosurg. 1996 Mar;84(3):494-502. doi: 10.3171/jns.1996.84.3.0494.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Glioblastoma
- Pituitary Neoplasms
- Pituitary Diseases
- Brain Neoplasms
Other Study ID Numbers
- 790089
- 79-N-0089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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