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Evaluation of Factors in Human Brain Tumors

Study Purpose

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.

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	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

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.	NCT00001171
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.	National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Completed
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Neoplasm, Glioblastoma, Glioma, Pituitary Neoplasm

Additional Details

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.

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.

Bethesda, Maryland

Status

Address

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892

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