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，多机构合作小组研究，旨在评估对高原期骨髓瘤患者的白介素12的毒性和功效，以维持缓解。 由于IL-12在引起小鼠肿瘤耐药性方面的功效，并且由于骨髓瘤的进展与TH1的降低和细胞毒性T细胞活性的相关性，因此在该试验的两个臂中，IL-12都与高原阶段的骨髓瘤患者一起施用IL-12，以帮助维持缓解。 IL-12的有效性将评估对肺炎球菌和血友病疫苗疫苗的反应。 IL-12对增强正常免疫胶蛋白的影响也将受到监测。