Gliomas Clinical Trial
Official title:
A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes
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.
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.
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