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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01251913
First received: December 1, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.

Condition
Ependymomas
Gliomas
PNET
Pineal Tumors
PCNSL (Primary CNS Lymphoma)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Pilot Study of Inpatient Hospice With Procurement of Brain Tumor Tissue on Expiration for Research Purposes

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Provide high quality end of life inpatient hospice care for patients dying with untreatable brain tumors. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procure brain and tumor tissue shortly after time of death in order to derive viable tumor and neural stem cell lines for research purposes. [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: November 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251913

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine E Warren, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01251913     History of Changes
Other Study ID Numbers: 110036, 11-C-0036
Study First Received: December 1, 2010
Last Updated: June 20, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Tissue Harvest
Hospice
Autopsy
Crainiotomy
Brain Tumor
Glioma
Astrocytoma

Additional relevant MeSH terms:
Brain Neoplasms
Ependymoma
Glioma
Lymphoma
Pinealoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014