CLINICAL TRIAL: A PHASE I STUDY OF ZOLEDRONIC ACID (ZOMETA) WITH CYCLOPHOSPHAMID

临床试验：唑来膦酸 (ZOMETA) 与环磷酰胺的 I 期研究

• 批准号: 7950608
• 负责人: HEIDI V RUSSELL
• 金额: $ 0.12万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950608
• 关键词: Behavior; Bone Resorption; Child; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Correlative Study; Cyclophosphamide; Dose; Drug Kinetics; Funding; Grant; Growth Factor; Institution; Intravenous infusion procedures; Maximum Tolerated Dose; Neuroblastoma; Oral; Patients; Phase I Clinical Trials; Recurrence; Refractory; Research; Research Personnel; Resources; Schedule; Source; T-Lymphocyte; Toxic effect; United States National Institutes of Health; Zoledronate; Zoledronic Acid; bone; cytokine

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Zometa will be tolerated and active in patients with recurrent or refractoryneuroblastoma. SPECIFIC AIMS Primary Aims: 1. To determine the maximum tolerated dose of Zometa given as a 15 minute intravenous infusion with a fixed dose of concomitant oral cyclophosphamide when administered in 28 day courses to children with recurrent or refractory neuroblastoma. 2. To determine the toxicities of Zometa given on this schedule. Secondary Aims: 1. To preliminarily evaluate the antitumor activity of Zometa and concomitant oral cyclophosphamide in children with recurrent and/or refractory neuroblastoma within the confines of a Phase I study. 2. To evlauate the pharmacokinetic behavior of Zometa in children with recurrent or refractory neuroblastoma. 3. To obtain preliminary information about the biologic activity of Zometa in neuroblastoma through correlative studies assessing change in markers of bone resorption, cytokines and bone-related growth factors, and gamma-delta T-cells.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 Zometa 对复发性或难治性神经母细胞瘤患者具有耐受性和活性。 具体目标 主要目的： 1. 确定对患有复发性或难治性神经母细胞瘤的儿童进行 28 天疗程时，以 15 分钟静脉输注与固定剂量口服环磷酰胺联合给药的 Zometa 的最大耐受剂量。 2. 确定本表中给予的 Zometa 的毒性。 次要目标： 1. 在 I 期研究范围内初步评估 Zometa 和同时口服环磷酰胺对患有复发性和/或难治性神经母细胞瘤的儿童的抗肿瘤活性。 2. 评估 Zometa 在患有复发性或难治性神经母细胞瘤的儿童中的药代动力学行为。 3. 通过评估骨吸收标志物、细胞因子和骨相关生长因子以及γ-δ T细胞变化的相关研究，获得Zometa在神经母细胞瘤中的生物学活性的初步信息。