CONTINUOUS 21 DAY INFUSION OF TOPOTECAN IN CHILDREN WITH RELAPSED SOLID TUMORS

患有复发性实体瘤的儿童连续 21 天输注拓扑替康

• 批准号: 6244708
• 负责人: RAYMOND J HUTCHINSON
• 金额: $ 2.22万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-02-20 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6244708
• 关键词: child (0-11); clinical research; drug administration rate /duration; drug screening /evaluation; human subject; human therapy evaluation; injection /infusion; leukemia; neoplasm /cancer chemotherapy; neoplasm /cancer relapse /recurrence; pediatric neoplasm /cancer; pediatric pharmacology; topotecan

The objective of this protocol is to determine a safe dose of a 21-day continuous infusion of topotecan administered to children with relapsed solid tumors and no bone marrow involvement. This dose will then be used in a phase-II trial in children with relapsed leukemia and possibly in children with relapsed solid tumors. If active in leukemia as a single agent, topotecan will probably have its major use in maintenance therapy. Severe myelosuppression should be avoided during maintenance treatment. Therefore, the pediatric MTD must be found in patients without bone marrow disease. This MTD would allow future studies of this schedule in children with leukemia or solid tumors.

本方案的目的是确定21天的安全剂量 托泊替康持续输注治疗复发性支气管哮喘 实体瘤没有骨髓受累 然后，该剂量将 用于复发性白血病儿童的II期试验， 复发性实体瘤的儿童。 如果在白血病中活跃， 单药拓扑替康可能主要用于维护 疗法 维持治疗期间应避免严重骨髓抑制 治疗 因此，必须在患者中发现儿科MTD 没有骨髓疾病。 该MTD将允许未来的研究 这个时间表在患有白血病或实体瘤的儿童中。