Brain Tumor Clinical and Clinical Research Program

为完成为患有脑和脊髓肿瘤的儿童和成人开发新的和改进的治疗方法的使命，国家统计局在建立必要的基础设施方面取得了实质性进展。以下是在建立脑肿瘤临床和临床研究计划方面的部分成就：建立了一个覆盖NIH的多学科脑瘤诊所，积极参与的有三个不同的NCI分支机构(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项目(神经放射学、精神病学、疼痛和缓解、康复医学、社会工作)。诊所的专业知识包括内科肿瘤学、儿科肿瘤学、放射肿瘤学、神经外科、神经病学、眼科、心脏病学、精神病学、内分泌学、社会工作和康复医学；组建了一个初级神经肿瘤学临床护理/研究团队，目前由4名神经肿瘤学家、6名受训的神经肿瘤学执业护士、3名研究护士、1名神经肿瘤学研究员、2名患者协调员、1名研究协调员和5名数据经理组成；建立了强大的神经肿瘤学咨询服务，在NIH看当地/地区的患者并对其进行跟踪(所有患者都累积到CNS肿瘤自然病史方案；远程患者可能只审查放射学/医疗记录；作为搜索委员会的主席，Howard Fine帮助NINDS/NCI招募了两名新的终身教职跟踪临床医生/科学家脑肿瘤神经外科医生，导致在NINDS外科神经科总共有5名临床活跃的脑瘤神经外科医生；启动了30多个IRB批准的临床试验，另外4个预计将在2005年秋季获得批准，总共有30个方案，而NIH在2000年NOB成立时只有1个方案用于原发脑瘤(这是以前的放射方案，总共只有不到10名患者)。这30个新方案包括：每年有200多名原发脑瘤患者参加NOB IRB批准的临床试验；在过去12个月里，有500多名新的原发脑瘤患者(几乎所有胶质瘤)和2000-3000名随访患者，而在NOB成立前一年(1999年)，NIH看到的恶性脑瘤患者不到10名。此外，NOB每周审查2-6个新的邮寄来的患者咨询。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；是CTEP的正式成员和参与成员，并为CTEP赞助的脑瘤临床试验财团(NABTC、NABTT)提供翻译科学专业知识；与约翰·霍普金斯医学中心、乔治·华盛顿医学中心、费尔法克斯·伊诺瓦和华盛顿医院中心以及当地和全国范围内的一系列私人神经外科、放射和肿瘤学实践团体建立了密切合作的临床项目；创建了美国为数不多的有组织的神经肿瘤学奖学金培训计划之一，这是由美国国立卫生研究院、约翰·霍普金斯医学中心和华盛顿特区的儿童国家医学中心组成的三机构联合研究培训计划；通过临床前筛选计划确定了五种化合物，此后已在NIH进行临床试验(CC8490、LY317615、VELCADE+Tamoxifen、CC5013、Talampanel)。启动了9项临床试验，这是神经肿瘤学实验室内进行的翻译工作的直接结果。

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, Pediatric 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, 1 neuro-oncology fellow, 2 patient coordinators, 1 study coordinator, 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 by fall 2005, for a total of 30 protocolscompared 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 less than 10 patients in total). The 30 new protocols comprise: Accrue more than 200 primary brain tumor patients to NOB IRB-approved clinical trials per year; Saw more than 500 new primary brain tumor patients (almost all gliomas) and between 2000-3000 follow-up patients over the last 12 months, up from less than 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; Is a full official and participating member and provides translational scientific expertise to both CTEP-sponsored brain tumor clinical trial consortia (NABTC, NABTT); 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). Activated 9 clinical trials as a direct result of translational work performed within the Neuro-Oncology Laboratory.