PHASE I TRIAL OF INTRAVENOUS FENRETINIDE (4-HPR) FOR PATIENTS WITH HEMATOLOGI

针对血液病患者静脉注射芬维A胺 (4-HPR) 的 I 期试验

• 批准号: 7716693
• 负责人: ANN F MOHRBACHER
• 金额: $ 15.5万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-20 至 2008-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7716693
• 关键词: Adult; Biological Availability; Breast; Cell Line; Child; Computer Retrieval of Information on Scientific Projects Database; Drug Formulations; Fenretinide; Funding; Grant; Hematologic Neoplasms; Institution; Intravenous; Intravenous Fat Emulsions; Malignant neoplasm of ovary; Neuroblastoma; Oral; Patients; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Research; Research Personnel; Resources; Safety; Serum; Source; Testing; Titrations; Toxic effect; United States National Institutes of Health; cytotoxicity; design; leukemia; tumor

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. This is a Phase I Trial of Intravenous Fenretinide (4-HPR) for patients with Hematologic Malignancies using an accelerated titration design. Fenretinide has been tested in oral formulation in treatment of breast and ovarian cancer in adults, and in neuroblastoma in children. Poor bioavailability of the oral drug precludes reaching serum levels shown to have direct tumor cytotoxicity for leukemia and lympoma cell lines. This phase I trial will assess safety, feasibilty, and toxicity of a new intravenous lipid emulsion formulation of fenretinide in patients with Hematologic Malignancies.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项采用加速滴定设计的静脉注射芬维A胺（4-HPR）治疗血液系统恶性肿瘤患者的I期试验。 芬维A胺已在口服制剂中测试用于治疗成人乳腺癌和卵巢癌以及儿童神经母细胞瘤。 口服药物的生物利用度差，无法达到对白血病和恶性肿瘤细胞系具有直接肿瘤细胞毒性的血清水平。 这项I期试验将评估一种新型芬维A胺静脉注射脂肪乳剂制剂在血液系统恶性肿瘤患者中的安全性、可行性和毒性。