EpendymomasNCT01251913
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
An observational study of Ependymomas and Gliomas, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: An important new area of brain tumor research is the development of tumor and brain stem cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh tumor and brain tissue, which is best accomplished by harvesting whole brains from recently deceased patients. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ependymomas, Gliomas, PNET
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2010to 29 Apr 2015
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary brain tumors including glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), low grade astrocytoma, low grade oligoastrocytoma, low grade oligodendroglioma, astrocytoma NOS (not otherwise specified), radiographically diagnosed brain stem gliomas, primitive neuroectodermal tumors (PNETs, including medulloblastomas, supratentorial PNET), pineal tumors, glioneuronal tumors, ependymomas and primary central nervous system lymphomas.
- All patients or their LAR (Legally Authorized Individual) (if the patient is deemed by the treating physician to be impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Patients or their LAR and their legal next of kin must agree to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan.
- Patients must be greater than or equal to 18 years old, and with a life expectancy < two weeks.
- This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate.
Who cannot join
- Known to be pregnant (known positive pregnancy test although such testing is not a requirement for enrollment).
- HIV-positive patients or those suspected of infectious cerebritis/abscess are ineligible because of the potential for contamination of brain tissue.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- An important new area of brain tumor research is the development of tumor and brain stem cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh tumor and brain tissue, which is best accomplished by harvesting whole brains from recently deceased patients. These cell lines will help researchers understand how these tumors develop and will also help identify new targets for treatment. Researchers are interested in conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue harvest at the time of death.
Read more
Objectives:
- To provide high-quality end of life inpatient hospice care for patients with untreatable brain tumors.
- To procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
Eligibility:
- Individuals at least 18 years of age who have an untreatable primary brain or central nervous system tumor, are able to give informed consent (either their own or through a designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan.
- HIV-positive individuals or those suspected of having infectious cerebritis are not eligible because of the potential for contamination of brain tissue.
Design:
- Participants will be enrolled in inpatient hospice admission to the National Institutes of Health Clinical Center either from home or from an outside hospital once a study investigator estimates an expected survival of less than 2 weeks.
- Participants will receive palliative care at the Clinical Center. Care will be tailored to each participant depending on the information provided in the individual's end-of-life care plan.
- Supportive medications such as antiseizure medications and pain relievers will be administered as appropriate.
- At the time of death, researchers will follow standard procedures for notifying next of kin and will collect brain tissue and tumor samples from the deceased.
- Following tissue collection, the deceased will be released for autopsy and funeral procedures.
Read the detailed description
BACKGROUND:
- Patients treated by the Neuro-Oncology Branch (NOB) for their brain tumors unfortunately and commonly succumb to their disease. They and their loved ones often seek a way of adding meaning and utility to their death by agreeing to donate brain tumor tissue for laboratory research that may serve the medical community, and ultimately other patients, through better understanding of these rare diseases. Important new avenues of brain tumor research includes the molecular characterization of tumor tissue, and the development of tumor and neural stem cell lines. Successful growth of these cell lines requires acquisition of large volumes of fresh tumor and brain tissue that can best be accomplished by harvesting whole brains from recently deceased patients. In an effort to provide high quality end of life care, with the additional intent of facilitating efficient donation of brain tumor tissue at the time of death, we are conducting a pilot study of planned inpatient hospice care incorporating timely brain tumor tissue procurement at the time of expiration.
OBJECTIVES:
- Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
- Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
ELIGIBILITY:
- Adult patients with primary brain tumors.
DESIGN:
- This is a pilot study to assess feasibility of procuring viable brain and tumor tissue proximal to the time of death. Target accrual is 10 patients for brain harvest.
- Conditions
- Ependymomas, Gliomas, PNET, Pineal Tumors, PCNSL (Primary CNS Lymphoma)
- Keywords
- Tissue Harvest, Hospice, Autopsy, Crainiotomy, Brain Tumor, Glioma, Astrocytoma
- Medical subject headings
- Ependymoma, Glioma, Neuroectodermal Tumors, Primitive, Pinealoma, Brain Neoplasms, Astrocytoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
Secondary outcomes (1)
Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study start12 Nov 2010
- Study completion29 Apr 2015
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 EpendymomasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Katherine E Warren, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251913
- Sponsor's protocol ID
- 110036
- Other IDs
- 11-C-0036
- Status last verified
- 29 Apr 2015
- First submitted
- 1 Dec 2010
- Last updated
- 3 Dec 2019
- Results posted
- No
Publications
Deschavanne PJ, Fertil B. A review of human cell radiosensitivity in vitro. Int J Radiat Oncol Biol Phys. 1996 Jan 1;34(1):251-66. doi: 10.1016/0360-3016(95)02029-2.
PubMed 12118559Hecht BK, Turc-Carel C, Chatel M, Grellier P, Gioanni J, Attias R, Gaudray P, Hecht F. Cytogenetics of malignant gliomas: I. The autosomes with reference to rearrangements. Cancer Genet Cytogenet. 1995 Oct 1;84(1):1-8. doi: 10.1016/0165-4608(95)00091-7.
PubMed 7497435Pardal R, Clarke MF, Morrison SJ. Applying the principles of stem-cell biology to cancer. Nat Rev Cancer. 2003 Dec;3(12):895-902. doi: 10.1038/nrc1232. No abstract available.
PubMed 14737120
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
- ClinicalTrials.gov ID
- NCT01251913
- Acronym / sponsor ID
- 110036
- Conditions
- Ependymomas, Gliomas, PNET, Pineal Tumors, PCNSL (Primary CNS Lymphoma)
- Keywords
- Tissue Harvest, Hospice, Autopsy, Crainiotomy, Brain Tumor, Glioma, Astrocytoma
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Nov 2010
- Study completion
- 29 Apr 2015
- First posted
- 2 Dec 2010 (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.
Background:
- An important new area of brain tumor research is the development of tumor and brain stem cell lines. Successful growth of these cell lines requires obtaining large volumes of fresh tumor and brain tissue, which is best accomplished by harvesting whole brains from recently deceased patients. These cell lines will help researchers understand how these tumors develop and will also help identify new targets for treatment. Researchers are interested in conducting a pilot study of planned inpatient hospice care with timely brain tumor tissue harvest at the time of death.
Objectives:
- To provide high-quality end of life inpatient hospice care for patients with untreatable brain tumors.
- To procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
Eligibility:
- Individuals at least 18 years of age who have an untreatable primary brain or central nervous system tumor, are able to give informed consent (either their own or through a designated power of attorney), and have agreed to a Do Not Resuscitate order and Consent for Autopsy as part of the end-of-life care plan.
- HIV-positive individuals or those suspected of having infectious cerebritis are not eligible because of the potential for contamination of brain tissue.
Design:
- Participants will be enrolled in inpatient hospice admission to the National Institutes of Health Clinical Center either from home or from an outside hospital once a study investigator estimates an expected survival of less than 2 weeks.
- Participants will receive palliative care at the Clinical Center. Care will be tailored to each participant depending on the information provided in the individual's end-of-life care plan.
- Supportive medications such as antiseizure medications and pain relievers will be administered as appropriate.
- At the time of death, researchers will follow standard procedures for notifying next of kin and will collect brain tissue and tumor samples from the deceased.
- Following tissue collection, the deceased will be released for autopsy and funeral procedures.
Detailed description
BACKGROUND:
- Patients treated by the Neuro-Oncology Branch (NOB) for their brain tumors unfortunately and commonly succumb to their disease. They and their loved ones often seek a way of adding meaning and utility to their death by agreeing to donate brain tumor tissue for laboratory research that may serve the medical community, and ultimately other patients, through better understanding of these rare diseases. Important new avenues of brain tumor research includes the molecular characterization of tumor tissue, and the development of tumor and neural stem cell lines. Successful growth of these cell lines requires acquisition of large volumes of fresh tumor and brain tissue that can best be accomplished by harvesting whole brains from recently deceased patients. In an effort to provide high quality end of life care, with the additional intent of facilitating efficient donation of brain tumor tissue at the time of death, we are conducting a pilot study of planned inpatient hospice care incorporating timely brain tumor tissue procurement at the time of expiration.
OBJECTIVES:
- Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
- Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
ELIGIBILITY:
- Adult patients with primary brain tumors.
DESIGN:
- This is a pilot study to assess feasibility of procuring viable brain and tumor tissue proximal to the time of death. Target accrual is 10 patients for brain harvest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (2 listed)
- Known to be pregnant (known positive pregnancy test although such testing is not a requirement for enrollment).
- HIV-positive patients or those suspected of infectious cerebritis/abscess are ineligible because of the potential for contamination of brain tissue.
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
Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.
1 secondary outcome
Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 12118559Deschavanne PJ, Fertil B. A review of human cell radiosensitivity in vitro. Int J Radiat Oncol Biol Phys. 1996 Jan 1;34(1):251-66. doi: 10.1016/0360-3016(95)02029-2.
- Background: PubMed 7497435Hecht BK, Turc-Carel C, Chatel M, Grellier P, Gioanni J, Attias R, Gaudray P, Hecht F. Cytogenetics of malignant gliomas: I. The autosomes with reference to rearrangements. Cancer Genet Cytogenet. 1995 Oct 1;84(1):1-8. doi: 10.1016/0165-4608(95)00091-7.
- Background: PubMed 14737120Pardal R, Clarke MF, Morrison SJ. Applying the principles of stem-cell biology to cancer. Nat Rev Cancer. 2003 Dec;3(12):895-902. doi: 10.1038/nrc1232. No abstract available.
Related trials for Ependymomas
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
Recruiting
Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being
Brain Cancer
RecruitingPhase 1
Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer
Ependymoma, Medulloblastoma
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
Not yet recruitingPhase 2
Mirdametinib to Reduce the Size of Large/Giant Congenital Melanocytic Nevi in Children, Adolescents and Young Adults
LGCMN, Large and Giant Congenital Melanocytic Nevi
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.
Katherine E Warren, M.D. principal investigator
National Cancer Institute (NCI)
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 Ependymomas and Gliomas, run by National Cancer Institute (NCI) 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 3 Dec 2019. 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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01251913, 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 3 Dec 2019.