PHASE II TRIAL OF IV SODIUM PHENYLACETATE IN B CELL CLL

IV 苯乙酸钠在 B 细胞 CLL 中的 II 期试验

• 批准号: 6278555
• 负责人: T E WITZIG
• 金额: $ 2.03万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6278555
• 关键词: chronic lymphocytic leukemia; clinical research; drug screening /evaluation; human subject; human therapy evaluation; neoplasm /cancer chemotherapy; nonHodgkin's lymphoma; phenylacetates

The goals of this research study are 1) to learn if the drug, sodium phenylacetate (NaPA), is helpful against chronic lymphocytic leukemia and non-Hodgkin's lymphoma, and 2) to look at the side effects the drug causes when given over continued periods of time. This study utilizes sodium phenylacetate (NaPA) by continuous infusion for 6 months for patients with relapsed non-Hodgkin's lymphoma, multiple myeloma, and chronic lymphocytic leukemia. We have found the drug to be well-tolerated once the patient has achieved the optimal dose of the drug. Acute side effects have consisted of somnolence, tinnitis and decreased hearing, and nausea. These are dose-related and resolve within 24-48 hours after the drug is held. There have been no other significant organ toxicities and the drug is not myelosuppressive. Current plans are to propose additional trials of this class of drugs in combination with conventional chemotherapy agents. A Letter of Intent is being formulated.

这项研究的目的是1)了解钠这种药物是否有效