RPCEC00000010已完成2 期
Active specific immunotherapy with the 1E10 anti-idiotype vaccine in the treatment of patients with small-cell lung cancer.
Center of Molecular Immunology (CIM)0 个研究点目标入组 88 人开始时间: 2010年12月28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
- 88
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: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 o limit（—）
- 性别
- All
入选标准
- •1) Patients who have signed informed consent in writing. 2) Patients with measurable lesions and partial or stable responses upon QTP completion. 3 )Patients whose period of time between onco-specific treatment completion and initial vaccine ranges from 4 to 6 weeks. 4) Age >= 18 years. 5) General condition according to ECOG < 2 (Karnofsky > 60%). 6) Patients with organs and bone marrow working normally, according to the following parameters: Hemoglobin>=9g/L, Leucocytes>=3,000/ml, Absolute neutrophil counting>=1,500/ml, Platelet counting>=100,000/mL, Total bilirubin: within normal limits. TGP and TGO<=2.5 times the institutional normal upper limit. LDH: Within normal limits for each institution. Creatinine: within normal limits for each institution. Urea and glycemia: within normal limits for each institution. Total and fractionary proteins: within normal limits for each institution. 7) Life expectancy over 3 months.
排除标准
- •1) Pregnancy or breastfeeding. 2) Reproductive-age patients of both sexes not using appropriate contraceptive methods (intrauterine devices, hormonal contraceptives, barrier methods or tubal ligation). Males should also use contraceptive methods (vasectomy, use of condoms) during the treatment. 3) Patients on other drugs under research. 4) Patients with autoimmune diseases or decompensated chronic diseases. 5) Patients with acute allergic conditions or history of severe allergic reactions. 6) Patients with brain metastasis or previous history of demyelinating or inflammatory diseases of the peripheral or central nervous system. 7) Patients with uncontrolled intercurrent diseases including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric diseases leading to subject incompetence. 8) Patients with previous malignant diseases, except in situ cervix carcinoma or skin cancer (other than melanoma), adequately treated.
研究者
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