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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 3, 2008 |
| Start Date ICMJE | July 1979 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001171 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Evaluation of Factors in Human Brain Tumors |
| Official Title ICMJE | Evaluation of Biological, Immunological and Therapeutic Parameters in Brain Tumor Patients |
| Brief Summary | 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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 800 |
| Completion Date | September 2005 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | 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. |
| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001171 |
| Responsible Party | |
| Study ID Numbers ICMJE | 790089, 79-N-0089 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | September 2005 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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