RPCEC00000068已完成2 期
Active specific immunotherapy with NGcGM3/VSSP/Montanide ISA 51 vaccine in metastatic breast cancer patient treatment. Phase II.
Center of Molecular Immunology (CIM)0 个研究点目标入组 80 人开始时间: 2010年12月17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
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- Female
入选标准
- •1.Patients with metastatic breast cancer (Stage IV or evolutive) with cito-histologic confirmation with the exception of bone lesions as the only site of metastases. 2.Patients who had finished their oncospecific treatment at least 4 weeks before entering the study. 3.Patients with signed informed consent. 4.Patients between 18 and 80 years old. 5.At least 6 months of life expectancy. 6.Patients with Performance Status between 0 and 2, according to WHO criteria (ECOG 0-2). 7.Laboratory parameters: a.-) Hb>=90g/L - Neutrophils .000/mm3 - Platelets >= 100 x 109 cells/Lb.-) Hepatics = 3 times upper normal limit - Bilirubin: 17 mol/L (LSN) - ALT: 40 U/L (LSN) - AST: 40 U/L (LSN) - Alkaline Phosphatase: 279 U/Lc.-) Creatinine ? 132 ?mol/L 8.Female patients.
排除标准
- •1.Patients with metastatic breast cancer (Stage IV or evolutive) suitable for oncospecific treatments not available in Cuba. 2.Patients who had received their oncospecific treatments within the 4 weeks before entering the study. 3.Patients who had finished their oncospecific treatment 6 months or longer before entering the study. 4.Pregnancy or breast feeding. 5.Brain metastases or history of inflamatory CNS diseases. 6.Previous malignant disease, except for cervix carcinoma in situ or non melanoma skin lesions. 7.Acute or cronic infectious diseases. 8.Patients with acute alergic states or history of severe alergic reactions. 9.Autoimmune diseases or uncontrolled cronic diseases. 10.Patients with as unique site of metastasis the contralateral breast.
研究者
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