PHASE II STUDY OF INTERLEUKIN 12 FOR PLATEAU PHASE MULTIPLE MYELOMA

白细胞介素 12 治疗平台期多发性骨髓瘤的 II 期研究

• 批准号: 6304154
• 负责人: ANNE M TRAYNOR
• 金额: $ 2.05万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304154
• 关键词: clinical research; cooperative study; human subject; human therapy evaluation; immunoglobulins; influenza vaccines; interleukin 12; multiple myeloma; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer remission /regression

This is a phase II randomized, multi-institutional cooperative group study designed to evaluate toxicity and efficacy of interleukin-12 given to plateau phase myeloma patients, in order to sustain remission. Because of IL-12's efficacy in causing tumor resistance in mice, and because of the correlation of progression in myeloma with decreased Th1 and cytotoxic T-cell activity, Il-12 is being administered in both arms of this trial to myeloma patients in plateau phase to help sustain remission. Effectiveness of IL-12 to enhance response to pneumococcal and hemophilus influenza B vaccines will be evaluated. Effect of IL-12 in boosting normal immunoglubulins will also be monitored.

这是一项II期随机化、多机构合作组研究，旨在评估白细胞介素-12对平台期骨髓瘤患者的毒性和疗效，以维持缓解。 由于IL-12在小鼠中引起肿瘤抗性的功效，并且由于骨髓瘤的进展与Th 1和细胞毒性T细胞活性降低的相关性，IL-12在本试验的两个组中被给予处于平台期的骨髓瘤患者以帮助维持缓解。将评价IL-12增强对肺炎球菌和流感嗜血杆菌B疫苗应答的有效性。还将监测IL-12在加强正常免疫球蛋白中的作用。