Gliomas Clinical Trial
Official title:
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
Verified date | April 29, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 7 |
Est. completion date | April 29, 2015 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
- INCLUSION CRITERIA: 1. 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. 2. 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. 3. 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. 4. Patients must be greater than or equal to 18 years old, and with a life expectancy < two weeks. 5. 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. EXCLUSION CRITERIA: 1. Known to be pregnant (known positive pregnancy test although such testing is not a requirement for enrollment). 2. HIV-positive patients or those suspected of infectious cerebritis/abscess are ineligible because of the potential for contamination of brain tissue. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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. Review. — View Citation
Hecht 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. — View Citation
Pardal R, Clarke MF, Morrison SJ. Applying the principles of stem-cell biology to cancer. Nat Rev Cancer. 2003 Dec;3(12):895-902. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors. | |||
Secondary | Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes. |
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