Brain NeoplasmNCT00001171
Evaluation of Factors in Human Brain Tumors
An observational study of Brain Neoplasm and Glioblastoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Neoplasm, Glioblastoma, Glioma
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1979to Sep 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Neoplasm, Glioblastoma, Glioma, Pituitary Neoplasm
- Keywords
- Brain Tumors, Glioma, Glioblastoma Multiforme, Pituitary Adenoma
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Glioma, Pituitary Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1979
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 800 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001171
- Sponsor's protocol ID
- 790089
- Other IDs
- 79-N-0089
- Status last verified
- Sep 2005
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 9145719Mason 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.
PubMed 9285597Zunkeler 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.
PubMed 8609564
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological, Immunological and Therapeutic Parameters in Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT00001171
- Acronym / sponsor ID
- 790089
- Conditions
- Brain Neoplasm, Glioblastoma, Glioma, Pituitary Neoplasm
- Keywords
- Brain Tumors, Glioma, Glioblastoma Multiforme, Pituitary Adenoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jul 1979
- Study completion
- Sep 2005
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9145719Manski 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.
- Background: PubMed 9285597Mason 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.
- Background: PubMed 8609564Zunkeler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasm and Glioblastoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001171, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.