CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS-TASK A

生物反应调节剂的临床试验-任务A

• 批准号: 2468735
• 负责人: ALBERT F LOBUGLIO
• 金额: $ 56.73万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-08-19 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2468735
• 关键词: biological response modifiers; clinical research; clinical trials; human subject; human therapy evaluation; neoplasm /cancer immunotherapy

This project is an interdisciplinary research effort involving radiation biology, radiation physics, radiation oncology, medical oncology, and immunology relating to the clinical evaluation of new targeting molecules, including genetically engineered antibodies, antibody fragments and fusion proteins, for the selective delivery of radioactive isotopes, toxins or immunologic attack mechanisms. Initial clinical protocols currently underway include the use of intraperitoneal 177Lu- labeled CC49 by intraperitoneal infusion, in the presence of varying amounts of taxol (radiosensitizer), in the treatment of recurrent ovarian cancer (modest tumor burden). Additional clinical protocols are examining the use of total body irradiation plus I31I-radiolabeled antibodies utilizing autologous stem cell support to explore marrow ablative dosage regimens in prostate and breast carcinoma. This program will shortly initiate studies to examine monoclonal antibodies to EGF receptor, in combination with external beam radiation for the treatment of head and neck cancer. These studies include both toxicity, clinical efficacy, pharmacokinetics, immunogenicity, and tissue localization components, in order to scientifically evaluate the efficacy or shortcomings of these strategies. We will be further evaluating other new targeting agents for inclusion into future phase I and phase II clinical trials.

该项目是一项涉及辐射的跨学科研究工作。 生物学、放射物理学、放射肿瘤学、医学肿瘤学和 与新靶向临床评价相关的免疫学研究 分子，包括基因工程抗体，抗体 用于选择性输送放射性物质的碎片和融合蛋白 同位素、毒素或免疫攻击机制。初期临床 目前正在进行的方案包括使用腹膜腔177Lu- 标记CC49，在不同药物存在的情况下，通过腹腔注射 紫杉醇(放射增敏剂)用量在复发性卵巢癌治疗中的应用 癌症(适度的肿瘤负担)。其他临床方案包括 检查全身照射加I31I-放射性标记的使用 利用自体干细胞支持的抗体探索骨髓 前列腺癌和乳腺癌的消融剂量方案。本节目 不久将启动检测EGF单抗的研究 受体联合外照射治疗 头部和颈部癌症。这些研究包括毒性、临床试验 疗效、药代动力学、免疫原性和组织定位 成分，以便科学地评价疗效或 这些策略的不足之处。我们将进一步评估其他 纳入未来第一阶段和第二阶段的新靶向药物 临床试验。