CLINICAL TRIAL: A PHASE 1 TRIAL OF ESCALATING DOSES OF KARENITECIN PLUS CYCLOPHO

临床试验：Karenitecin 加 CYCLOPHO 剂量递增的 1 期试验

• 批准号: 7950646
• 负责人: SUSAN M. BLANEY
• 金额: $ 5.15万
• 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/7950646
• 关键词: Bone Marrow; Child; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cyclophosphamide; Dose; Funding; Grant; Institution; Karenitecin; Maximum Tolerated Dose; Myelosuppressive Therapy; Neoplasm Metastasis; Patients; Phase; Phase I Clinical Trials; Recurrence; Refractory; Research; Research Personnel; Resources; Solid Neoplasm; Source; Toxic effect; United States National Institutes of Health

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. Primary Objective: The primary objective of this study is to determine the maximum tolerated dose (MTD) levels and recommended Phase 2 dose levels of Karenitecin when administered intravenously for 5 consecutive days repeated every 21 days concurrently administered with a fixed dose of cyclophosphamide to children with refractory or recurrent solid tumors stratified according to the following: * patients with bone marrow metastases or those who have received previous intensive myelosuppressive therapy (Stratum 1). * patients without bone marrow metastases or those who have not received previous intensive myelosuppressive therapy (Stratum 2). Secondary Objective(s): The secondary objectives of this study include the following: * To assess the toxicity associated with Karenitecin administered in combination with cyclophosphamide. * To assess the antitumor activity of Karenitecin administered in combination with cyclophosphamide.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 主要目的：本研究的主要目的是确定最大耐受量(MTD)。 卡列奈特素静脉给药5次时的血药浓度和推荐的2期剂量水平 连续给药，每21天重复一次，同时服用固定剂量的环磷酰胺 对于患有难治性或复发性实体瘤的儿童，按以下分层：*骨病患 骨髓转移或以前接受过强化骨髓抑制治疗的患者(第1层)。* 无骨髓转移或未接受过强化治疗的患者 骨髓抑制疗法(第2层)。 次要目标(S)：本研究的次要目标包括：*评估毒性 与环磷酰胺联合应用Karenitecin有关。*评估Karenitecin与环磷酰胺联合应用的抗肿瘤活性。