RECOMBINANT KERATINOCYTE GROWTH FACTOR IN HEAD & NECK CANCER

头部重组角质细胞生长因子

• 批准号: 6263437
• 负责人: RUBY F. MEREDITH
• 金额: $ 2.95万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263437
• 关键词: clinical research; clinical trials; combination therapy; dosage; fibroblast growth factor; head /neck neoplasm; human subject; human therapy evaluation; inflammation; mucus; neoplasm /cancer chemotherapy; neoplasm /cancer radiation therapy; recombinant proteins; xerostomias

Mucositis results in considerable morbidity and often undesired treatment interruption during definitive treatment for head and neck cancer with radiation +/- chemotherapy. A Phase I/II study of recombinant keratinocyte growth factor (KGF) is proposed in an attempt to overcome severe mucositis. Preliminary information including testing of recombinant keratinocyte growth factor in human volunteers and its interaction with therapeutic agents has been accomplished. Eligible patients with locally advanced head and neck cancer will receive definitive radiation + chemotherapy in a randomized, double-blind, placebo-controlled dose escalation study. Three dose levels are planned with the initiation of growth factor prior to radiation/chemotherapy and repeated weekly. Patients will be evaluated for acute effects up to 2 months after therapy and for lingering xerostomia, other late effects and quality of life for 1 year. Future studies would define the optimal dose and timing of KGF for head and neck cancer patients and adapt this agent for treatment of other sites (lung and esophagus) which are also affected by mucositis.

粘膜炎导致相当大的发病率，并且在使用放射+/-化学疗法的头颈癌的确定性治疗期间通常不期望的治疗中断。 重组角质细胞生长因子（KGF）的I/II期研究提出了试图克服严重的粘膜炎。初步的信息，包括测试重组角质细胞生长因子在人类志愿者和它的相互作用与治疗药物已经完成。 符合条件的局部晚期头颈癌患者将在一项随机、双盲、安慰剂对照剂量递增研究中接受确定性放疗+化疗。 计划在放疗/化疗前开始使用生长因子，每周重复一次，共使用三个剂量水平。 将在治疗后2个月内评价患者的急性效应，并在1年内评价持续性口干、其他晚期效应和生活质量。 未来的研究将确定KGF用于头颈癌患者的最佳剂量和时间，并使该药物适用于治疗也受粘膜炎影响的其他部位（肺和食管）。