CLINICAL TRIAL: PBTC-019: A PHASE I PHARMACOKINETIC OPTIMAL DOSING STUDY OF INT

临床试验：PBTC-019：INT 的 I 期药代动力学最佳剂量研究

• 批准号: 8356671
• 负责人: SUSAN M. BLANEY
• 金额: $ 0.91万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-12-01 至 2011-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8356671
• 关键词: Biological Markers; Cerebrum; Child; Clinical Research; Clinical Trials; Disease; Dose; Dose-Limiting; Drug Kinetics; Funding; Grant; Image; Intraventricular; Lactones; Matrix Metalloproteinases; Metastatic Neoplasm to the Leptomeninges; National Center for Research Resources; Patients; Phase; Principal Investigator; Research; Research Infrastructure; Resources; Source; Topotecan; Toxic effect; United States National Institutes of Health; Vascular Endothelial Growth Factors; cost; response; tumor

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Hypothesis: Intrathecal topotecan will have anti-tumor activity in children with neoplastic meningitis. Specific Aims: Primary Objectives 1. To estimate the MTD of intraventricular topotecan administered daily for 5 consecutive days. 2. To describe the toxicities and define the dose-limiting toxicity of topotecan following intraventricular administration daily for 5 consecutive days. 3. To determine if the MTD of intraventricular topotecan is also a pharmacokinetic optimal dose as defined by topotecan lactone concentrations in the cerebral CSF. Secondary Objectives 1. To provide preliminary descriptions of the anti-tumor activity of intraventricular topotecan observed in the heterogeneous diseases that will be treated in this trial. 2. To investigate MMP, VEGF, and other potential biological markers in the CSF of patients with neoplastic meningitis prior to and throughout treatment with intraventricular topotecan. 3. To further describe the CSF pharmacokinetics of topotecan following CSF administration. 4. To investigate the feasibility of central review imaging following treatment and to correlate observed effects with response to intraventricular therapy.

该副本是利用资源的众多研究子项目之一 由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持 而且，副投影的主要研究员可能是其他来源提供的 包括其他NIH来源。 列出的总费用可能 代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。 假设： 鞘内拓扑替康将在肿瘤性脑膜炎儿童中具有抗肿瘤活性。 具体目的： 主要目标 1。估计每天连续5天给药的脑室内拓扑替康的MTD。 2。描述毒性并定义脑室内给药后拓扑替康的剂量限制毒性 每天连续5天。 3。确定脑室内拓扑替克的MTD是否也是拓扑替康定义的药代动力学最佳剂量 大脑CSF中的内酯浓度。 次要目标 1。提供对脑室内拓扑替康的抗肿瘤活性的初步描述。 在此试验中将治疗的异质疾病。 2。研究CSF的MMP，VEGF和其他潜在的生物标记患者的肿瘤性脑膜炎患者 脑室拓扑替康之前和整个治疗。 3。进一步描述CSF给药后拓扑替康的CSF药代动力学。 4。研究处理后中央审查成像的可行性，并将观察到的影响与 对脑室室疗法的反应。