PHASE II STUDY OF RHIL 12 IV INJECTIONS IN ADVANCED MALIGNANT MELANOMA PATIENTS

晚期恶性黑色素瘤患者注射 RHIL 12 IV 的 II 期研究

• 批准号: 6219286
• 负责人: John Munn Kirkwood
• 金额: $ 0.3万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 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/6219286
• 关键词: clinical research; dosage; drug screening /evaluation; human subject; human therapy evaluation; interleukin 12; intravenous administration; melanoma; metastasis; neoplasm /cancer classification /staging; neoplasm /cancer immunotherapy; recombinant proteins

The primary objective of this multicenter, open-label Phase II study is to determine the tumor response of rhIL-12 administered by intravenous injection in patients with advanced malignant melanoma. Patients will continue therapy for a period of three multiple dose cycles or until there is disease progression or toxicity associated with rhIL-12. If the patient has an objective response or stable disease after three multiple dose cycles, therapy may be continued for a maximum of 15 multiple dose cycles of rhIL-12 treatment. Findings suggest that IL-12 is active against a variety of murine tumors and that multiple mechanisms may play a role in the antitumor activity of IL-12. The secondary objective is to assess the safety of this dose schedule and route of administration.

这项多中心、开放标签的 II 期研究的主要目的是确定静脉注射 rhIL-12 对晚期恶性黑色素瘤患者的肿瘤反应。 患者将继续治疗三个多剂量周期，或者直到出现与 rhIL-12 相关的疾病进展或毒性。 如果患者在三个多剂量周期后出现客观缓解或疾病稳定，则可以继续治疗最多 15 个 rhIL-12 多剂量周期。 研究结果表明，IL-12 对多种小鼠肿瘤具有活性，多种机制可能在 IL-12 的抗肿瘤活性中发挥作用。 第二个目标是评估该剂量方案和给药途径的安全性。