Brain Tumor Clinical and Clinical Research Program

脑肿瘤临床和临床研究计划

• 批准号: 8554177
• 负责人: Howard Fine
• 金额: $ 361.71万
• 依托单位: DIVISION OF BASIC SCIENCES - NCI
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8554177
• 关键词: Adult; Autopsy; Basic Science; Biotechnology; Brain; Brain Neoplasms; Brain region; CC-5013; Cardiology; Caring; Central Nervous System Neoplasms; Cephalic; Cessation of life; Child; Clinic; Clinical; Clinical Research; Clinical Sciences; Clinical Trials; Communities; Consult; Consultations; Cultured Tumor Cells; Data; Disease; Distant; District of Columbia; Endocrinology; Ensure; Family; Fellowship; Freezing; Genomics; Glioma; Group Practice; Heart Arrest; Heterogeneity; Hospitals; Hour; Human; Institution; Institutional Review Boards; Joints; LY317615; Laboratories; Mails; Malignant Glioma; Malignant Neoplasms; Malignant neoplasm of brain; Maps; Medical Oncology; Medical Records; Medical center; Medicine; Mission; National Cancer Institute; National Heart, Lung, and Blood Institute; National Institute of Mental Health; National Institute of Neurological Disorders and Stroke; Natural History; Neurology; Neurosurgeon; Normal tissue morphology; Nurse Practitioners; Nursing Research; Oncologic Nursing; Oncologist; Oncology Nurse; Operative Surgical Procedures; Ophthalmology; Pain; Patients; Pharmacologic Substance; Physicians; Pituitary Neoplasms; Primary Brain Neoplasms; Protocols documentation; Psychiatry; Radiation; Radiation Oncology; Radiology Specialty; Recruitment Activity; Rehabilitation therapy; Research; Research Infrastructure; Research Personnel; Research Training; Resources; Running; Sampling; Scientist; Screening procedure; Second Opinions; Services; Social Work; Specialist; Specimen; Spinal Cord Neoplasms; Sterility; Talampanel; Tamoxifen; Tissue Sample; Tissues; Training; Training Programs; Translational Research; Travel; Tumor Stem Cells; Tumor Tissue; United States National Institutes of Health; Velcade; Washington; Work; base; cell growth; clinical care; effective therapy; end of life; follow-up; hemangioblastoma; hospice environment; improved; multidisciplinary; neoplastic cell; neuro-oncology; neurosurgery; novel; novel therapeutics; oncology service; palliation; pre-clinical; programs; standard care; tumor

The NOB has made substantial progress towards building an infrastructure necessary for fulfilling its mission of developing new and improved therapies for children and adults with brain and spinal cord tumors. Below are partial lists of accomplishments in the building of the Brain Tumor Clinical and Clinical Research Program: Established an NIH-wide multidisciplinary Brain Tumor Clinic with active participation from three different NCI Branches (ROB, MOCRU, CCRLP), five different NIH Institutions (NCI, NINDS, NEI, NHLBI, NIMH), and five different Clinical Center Programs (Neuroradiology, Psychiatry, Pain and Palliation, Rehabilitation Medicine, Social Work). Expertise represented in the clinic includes Medical Oncology, Radiation Oncology, Neurosurgery, Neurology, Ophthalmology, Cardiology, Psychiatry, Endocrinology, Social Work, and Rehabilitation Medicine; Assembled a primary neuro-oncology clinical care/research team, which now consists of 4 neuro-oncologists, 6 NOB-trained neuro-oncology nurse practitioners, 3 research nurses, 2 neuro-oncology fellows, 2 patient coordinators, 2 clinical trials specialists and 5 data managers; Established a robust neuro-oncology consultation service, in which local/regional patients are seen and followed at the NIH (all patients are accrued to a CNS tumor natural history protocol; distant patients may just have radiology/medical records reviewed; Serving as Chair of the Search Committee, Howard Fine helped recruit two new tenure track clinician/scientist brain tumor neurosurgeons to NINDS/NCI leading to a total of 5 clinically active brain tumor neurosurgeons in the Surgical Neurology Branch, NINDS; Activated more than 30 IRB approved clinical trials with an additional 4 expected to be approved in the coming months, for a total of 30 protocols compared to just 1 protocol existing for primary brain tumors at the NIH when the NOB was formed in 2000 (a prior radiation protocol that had accrued 500 new primary brain tumor patients (almost all gliomas) and between 2000-3000 follow-up patients over the last 12 months, up from < 10 patients with malignant brain tumor seen at NIH in the year before the NOB was formed (1999). Additionally, the NOB reviews 2-6 new mail-in patient consults per week.Provides almost all neuro-oncology services for Walter Reed Medical Center, the Portsmouth Naval Hospital, and the Naval Medical Center in Bethesda; Established close collaborative clinical programs with Johns Hopkins Medical Center, George Washington Medical Center, Fairfax Inova and Washington Hospital Center and a wide array of private neurosurgical, radiation, and oncology practice groups locally and nationally; Created one of only a few organized neuro-oncology fellowship training programs in the United Statesa three-institution joint research training program between the NIH, Johns Hopkins Medical Center, and Childrens National Medical Center in Washington, D.C.; Identified five compounds through the preclinical screening program that have since been brought forward to clinical trials at the NIH (CC8490, LY317615, Velcade + Tamoxifen, CC5013, Talampanel, MLN518, Sunitinib).We have also initiated a truly unique study that could only be accomplished at the NIH and the Clinical Center for all practical purposes. In an effort to try and understand the intra-tumor heterogeneity found within the brain of a patient with malignant gliomas at a functional and tumor stem cell levels it is necessary to obtain viable tumor and normal tissue for all regions of the brain. Obviously such a sampling can not be done on alive patient but unfortunately, we have found that autopsy specimens that are as fresh as 12 hours from death are too old to grow viable tissue. Thus, we initiated a unique trial where patients and families who wish to donate their brains to brain tumor research are admitted to the Clinical Center shortly prior to death for hospice/end of life care. Immediately upon cardiac arrest thepatients body is quickly brought down to the surgical suite and under sterile surgical conditions the brain is removed from the cranial vault by one of our neurosurgeons and then quickly dissected with all of the appropriate tissue samples immediate frozen and/or put into culture for tumor cell growth. This study will give us unprecedented opportunity to construct a tumor cell-based genomic microanatomical map of a human brain harboring a GBM. This trial typifies the close and intertwined functioning of the clinical and basic science research effort of the NOB.Activated more than 9 clinical trials as a direct result of translational work performed within the Neuro-Oncology Laboratory.

NOB在建立必要的基础设施方面取得了实质性进展，以履行其使命，即为患有脑和脊髓肿瘤的儿童和成人开发新的和改进的疗法。以下是脑肿瘤临床和临床研究计划建设的部分成就列表：在三个不同的NCI分支机构的积极参与下，建立了NIH范围内的多学科脑肿瘤诊所（ROB，MOCRU，CCRLP），五个不同的NIH机构（NCI，NINDS，NEI，NHLBI，NIMH）和五个不同的临床中心计划（神经放射学，精神病学，疼痛和姑息，康复医学，社会工作）。诊所的专业知识包括肿瘤内科、放射肿瘤科、神经外科、神经科、眼科、心脏科、精神科、内分泌科、社会工作和康复医学;组建了一个主要的神经肿瘤学临床护理/研究团队，目前包括4名神经肿瘤学家、6名接受过NOB培训的神经肿瘤学执业护士、3名研究护士、2名神经肿瘤学研究员、2名患者协调员，2名临床试验专家和5名数据管理员;建立了强大的神经肿瘤咨询服务，在NIH为当地/区域患者提供咨询和随访（所有患者都应参加CNS肿瘤自然史方案;远处患者可能仅需要回顾放射学/医疗记录;作为遴选委员会主席，霍华德费恩帮助招募了两名新的终身制临床医生/科学家脑肿瘤神经外科医生到NINDS/NCI导致NINDS外科神经病学分支共有5名临床活跃的脑肿瘤神经外科医生;启动了30多项IRB批准的临床试验，预计在未来几个月内还将批准另外4项临床试验，与2000年NOB成立时NIH仅有的一个针对原发性脑肿瘤的方案相比，总共有30个方案（在过去的12个月中，已有500名新的原发性脑肿瘤患者（几乎所有的神经胶质瘤）和2000-3000名随访患者的先前放射方案，在<NOB成立前一年（1999年），NIH发现了10例恶性脑肿瘤患者。此外，NOB每周审查2-6个新的邮寄病人咨询，为沃尔特里德医疗中心、朴茨茅斯海军医院和贝塞斯达的海军医疗中心提供几乎所有的神经肿瘤学服务;与约翰霍普金斯医疗中心、乔治华盛顿医疗中心、费尔法克斯Inova和华盛顿医院中心以及各种私人神经外科、放射、创建了美国仅有的几个有组织的神经肿瘤学奖学金培训项目之一，一个由美国国立卫生研究院、约翰霍普金斯医学中心和华盛顿，华盛顿特区的儿童国家医学中心组成的三个机构联合研究培训项目;通过临床前筛选项目确定了五种化合物，这些化合物已在NIH进行临床试验（CC 8490、LY 317615、万珂+他莫昔芬、CC 5013、Talampanel、MLN 518、舒尼替尼）。我们还启动了一项真正独特的研究，该研究只能在NIH和临床中心完成，用于所有实际目的。 为了尝试和理解在功能和肿瘤干细胞水平上恶性神经胶质瘤患者脑内发现的肿瘤内异质性，有必要获得脑所有区域的活肿瘤和正常组织。 显然，这种取样不能在活着的病人身上进行，但不幸的是，我们发现，死亡后12小时新鲜的尸检标本太老了，无法生长出有活力的组织。 因此，我们启动了一项独特的试验，希望将大脑捐献给脑肿瘤研究的患者和家属在死亡前不久被送往临床中心接受临终关怀/临终关怀。 心脏骤停后，患者的身体立即被迅速带到手术室，在无菌手术条件下，我们的一名神经外科医生将大脑从颅穹窿中取出，然后迅速解剖，所有适当的组织样本立即冷冻和/或放入肿瘤细胞生长培养物中。 这项研究将为我们构建一个基于肿瘤细胞的人脑GBM基因组显微解剖图提供前所未有的机会。这项试验代表了NOB临床和基础科学研究工作的密切和相互交织的功能。作为神经肿瘤学实验室内进行的转化工作的直接结果，启动了9项以上的临床试验。