RHU MONOCLONAL ANTI VEGF ANTIBODY & CHEMO FOR SOLID MALIGNANCIES

RHU 单克隆抗 VEGF 抗体

• 批准号: 6265112
• 负责人: Michael Gordon
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 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/6265112
• 关键词: angiogenesis inhibitors; clinical research; clinical trial phase I; combination cancer therapy; human subject; human therapy evaluation; monoclonal antibody; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; vascular endothelial growth factors

Angiogenesis is known to be critical in the development and progression of breast cancer and other solid tumors. Recently the growth factor VEGF (Vascular Endothelial Growth Factor) has been implicated as a crucial growth factor in cancer metastasis and growth. As such, it represents a reasonable therapeutic target for the treatment of cancer. We have previously performed the phase I trial of anti-VEGF as a single agent and now propose to assess the safety and pharmacokinetic effects of combining anti-VEGF with chemotherapy based upon pre-clinical data which suggests improved therapeutic outcome when inhibitors of angiogenesis and chemotherapy are combined. This is a two center trial and we anticipate placing approximately half the patients on study. It appears that based upon drug availability that the study may not proceed beyond the first dose level and hence we expect to study ~6 patients. In addition to standard safety evaluation, pharmacokinetic analyses of VEGF, rhuMAb VEGF, and chemotherapy will be performed, using the services of the GCRC.

已知血管生成对于乳腺癌和其他实体瘤的发展和进展至关重要。 最近，生长因子VEGF（血管内皮生长因子）被认为是癌症转移和生长的关键生长因子。 因此，它代表了癌症治疗的合理治疗靶点。 我们以前曾进行过抗VEGF作为单一药物的I期试验，现在建议评估基于临床前数据将抗VEGF与化学疗法相结合的安全性和药代动力学作用，这表明当血管生成和化学疗法抑制剂时，这表明治疗结果得到了改善。合并。 这是一项两个中心试验，我们预计将大约将患者进行研究。 看来，基于药物的可用性，该研究可能不会超过第一个剂量水平，因此我们期望研究约6例患者。 除标准安全评估外，还将使用GCRC的服务进行VEGF，Rhumab VEGF和化学疗法的药代动力学分析。