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A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes


N/A
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Mixed Oligoastrocytoma

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Trial Information

A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes


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.

Inclusion Criteria


- 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.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Teri N Kreisl, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

110036

NCT ID:

NCT01251913

Start Date:

November 2010

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Gliosarcoma
  • Anaplastic Astrocytoma
  • Anaplastic Oligodendroglioma
  • Anaplastic Mixed Oligoastrocytoma
  • Tissue Harvest
  • Hospice
  • Autopsy
  • Crainiotomy
  • Brain Tumor
  • Glioma
  • Astrocytoma
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Oligodendroglioma
  • Gliosarcoma

Name

Location
National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda, Maryland  20892