JPRN-UMIN000007507已完成2 期
A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent breast cancers - Cancer vaccine study with Survivin helper peptide for patients with breast cancers
Department of Breast and Endocrine Surgery, Hokkaido University Hospital0 个研究点目标入组 40 人开始时间: 2012年3月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients treated with other cancer therapy within 4 weeks before the first vaccine 2) Patients treated with cancer immunotherapy for Survivin 3) Severe bleeding disorders, meeting the criteria below; PT<50% APTT>60sec 4) Active infection (HIV, HBV or HCV HTLV-1) 5) Severe heart disease (NYHA class 3 or 4) 6) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.) 7) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics). 8) Brain metastasis 9) Multiple primary cancer 10)Patients with adverse events more than Grade 3 (non-hematological toxicity ) or Grade 4 (hematological toxicity) based on CTCAEv4.0 11)Pregnant women or refuse anticonception during the study (both sexes) Patient with impaired mental status in the study. 12) Lactating women or cannot stop lactation during the study. 13) Men refused anticonception during the study 14) Inappropriate for study entry judged by an attending physician.
研究者
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