RPCEC00000006已完成2 期
Active specific immunotherapy with 1E10 anti-idiotype vaccine to treat patients with metastatic colon cancer, phase II.
Center of Molecular Immunology (CIM)0 个研究点目标入组 40 人开始时间: 2010年12月3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
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 19 years 至 one（—）
- 性别
- All
入选标准
- •1. Patients of any sex with colon adenocarcinoma phase IV or evolvable metastatic disease upon diagnosis, cyto-histological confirmation of the disease. Patients who have received any first-line onco-specific treatment for the disease and completed such treatment within the last six months. 2. Patient’s consent in writing to participate in the research. 3. Patients over 18 years of age. 4. Patients with a life expectancy of six months or more. 5. Patients with Grade 0 to 2 Performance Status evaluation, in keeping with WHO criteria. 6. Clinical laboratory parameters: a.-) Hematopoietic parameters: - Hb: 100g/l, leucocytes: 4 x 109cells/l, granulocytes: 2x109 cells/l, platelets: 100 x 109cells/ l. b.-) Liver (not exceeding the normal upper limit by three times), bilirubin: 17mol/l (LSN), ALAT: 40U/l (LSN), ASAT: 40U/l (LSN), alkaline phosphatase: 279U/l c.-) Kidney: serum creatinine: 132 ?mol/l.
排除标准
- •1. Patients who, before trial inclusion, have received first-line onco-specific therapy for metastatic disease, which is not established in national and international oncological standards, or have completed such treatment over 6 months prior to therapy. 2. Pregnancy or breastfeeding. 3. Patients with brain metastasis or a previous history of demyelinating or degenerative diseases of the peripheral or central nervous system. 4. Patients with appropriately treated malignant diseases, except in situ cervix carcinoma or skin cancer (other than melanoma). 5. Patients with acute or chronic infectious diseases. 6. Patients with acute allergic conditions or history of severe allergic reactions. 7. Patients with autoimmune diseases or decompensated chronic diseases. 8. Patients with local relapse or peritoneal carcinomatosis as the only lesion site. 9. Patients with intra-abdominal ganglia as the only site of metastatic location without cyto-histological confirmation.
研究者
相似试验
已完成
2 期
1E10 anti-idiotype vaccine, metastatic breast cancer, phase IIBreast carcinoma in stage IV or progressive metastatic diseaseBreast NeoplasmsCarcinomaBreast DiseasesRPCEC00000008Center of Molecular Immunology (CIM)80
已完成
2 期
Anti-idiotype 1E10 vaccine in the treatment of patients with small cell lung (SCLC) patientsAdvanced Lung Cancer Small Cell Lung CancerSmall Cell Lung CarcinomaCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesRPCEC00000010Center of Molecular Immunology (CIM)88
招募中
1 期
GcGM3/VSSP in small cell lung cancerCarcinoma, BronchogenicRespiratory Tract NeoplasmsLung NeoplasmsSmall cell lung cancerBronchial NeoplasmsSmall Cell Lung CarcinomaThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesRPCEC00000224Center of Molecular Immunology (CIM)40
招募中
2 期
GcGM3/VSSP in Metastatic melanomaMetastatic melanomaNevi and MelanomasNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueMelanomaRPCEC00000223Center of Molecular Immunology (CIM)160
尚未招募
2 期
GcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancerMetastatic hormone-receptor positive and HER2 negative breast cancerBreast NeoplasmsBreast DiseasesRPCEC00000220Center of Molecular Immunology (CIM)286