CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS

生物反应调节剂的临床试验

• 批准号: 2300875
• 负责人: ALBERT F LOBUGLIO
• 金额: $ 14.9万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1994
• 资助国家: 美国
• 起止时间: 1994-11-01 至 1999-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2300875
• 关键词: biological response modifiers; clinical trials; dosage; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; monoclonal antibody; neoplasm /cancer chemotherapy; neoplasm /cancer immunology; neoplasm /cancer immunotherapy; neoplasm /cancer pharmacology; pharmacokinetics

The Contractor will conduct clinical trials of biological response modifiers in cancer patients. Working with the Project Officer, the Contractor will identify two or more clinical trials to be conducted per contract year. Agents to be studied will be supplied by the government or otherwise approved by the Project Officer. All clinical protocols will be submitted to the Project Officer for NCI approval. The overall goal of the contract will be to address fundamental issues in the use of monoclonal antibodies and targeting agents in the treatment of patients with cancer. Each clinical trial will be developed, conducted, and analyzed as part of a specific Task Order. At a minimum, each protocol will assess the toxicity of the treatment regimen, explore mechanisms of antitumor effect and resistance, observe clinical antitumor responses, and monitor specific immunologic parameters appropriate to that clinical trial and approved by the Project Officer. At the conclusion of each clinical trial, the Contractor will summarize results in a written Report of Clinical Trial submitted to the Project Officer.

承包商将进行生物反应的临床试验 癌症患者的修饰剂。 与项目官员合作， 承包商将确定要进行的两项或多项临床试验 合同年。待研究的试剂将由政府或 另有项目官员批准的。 所有临床方案将 提交给项目官员以获得 NCI 批准。 总体目标为 该合同将解决使用中的基本问题 单克隆抗体和靶向药物在患者治疗中的应用 患有癌症。 每项临床试验都将作为项目的一部分进行开发、实施和分析 特定的任务订单。 每个协议至少将评估 治疗方案的毒性，探讨抗肿瘤作用机制 和耐药性，观察临床抗肿瘤反应，并监测特异性 适合该临床试验并经批准的免疫学参数 项目官员。 在每次临床试验结束时， 承包商将在书面临床试验报告中总结结果 提交给项目官员。