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

NCT01251913 | Terminated

• 2 other identifiers: 11003611-C-0036
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Tissue Harvest; Hospice; Autopsy; Crainiotomy; Brain Tumor; Glioma; Astrocytoma

Outcome Measures

Primary Outcomes (1)

• 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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12118559 BACKGROUND

• 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. doi: 10.1016/0165-4608(95)00091-7.

  PMID: 7497435 BACKGROUND

• Pardal 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.

  PMID: 14737120 BACKGROUND

MeSH Terms

Conditions

Ependymoma; Glioma; Neuroectodermal Tumors, Primitive; Pinealoma; Brain Neoplasms; Astrocytoma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Katherine E Warren, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: November 12, 2010
• Study Completion: April 29, 2015
• Last Updated: December 3, 2019

Record last verified: 2015-04-29

Locations

US (1)