RPCEC00000140尚未招募1 期
Study of tolerance of the intravenous CIGB-128-A application in recurrent and/or progressive diffuse brain tumors
Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 30 人开始时间: 2013年1月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 18 years 至 /A (No limit)（—）
- 性别
- All
入选标准
- •1. Age =18 years. 2. Patients with recurrent and/or progressive diffuse brain tumors (benign or malign), with a bad prognostic, without other therapeutic options, at any stage: meningiomas, ependymomas, diffuse astrocytoma, oligodendroglioma, oligoastrocytoma, anaplastic meningioma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma and glioblastoma multiforme, confirmed by histopathological techniques. 3. Recurrent and/or progressive disease diagnosed by imaging (CT scans, MRI) up to 14 days prior inclusion and after the patient has received the conventional treatment that their condition has allowed (Biopsy; Biopsy-RT; Surgery (radio-surgery or another); Surgery-RT; RT; Surgery-RT-Immunotherapy; Surgery-RT-Chemotherapy or another available therapy approved for this kind of patients). 4. Tumor of any size and localization. Taking more than one hemisphere or invasion of basal ganglion, callous body or ventricular system is not prohibited. 5. Karnofsky performance state = 60%. 6. Expectation of life = 8 weeks. 7. Clinical laboratory parameters (up to 7 days previous inclusion): • Hemoglobin = 10 g/L; total leukocytes count = 4 x 109 cells/L; platelets count = 150 x 109/L. • No hepatic alterations at entry demonstrated by AST, ALT or alkaline phosphatase. • Normal renal function: serum creatinine =132 µmol /L. • Normal ionogram. 8. Patients into fertile age should use an effective contraceptive method until three months after the treatment has concluded. 9. Written, informed consent to participate.
排除标准
- •1. Pregnancy, puerperium, or nursing. 2. Hypersensibility to CIGB-128-A or other preparations used in the trial. 3. Medically untreated convulsions. 4. Signs of medullar affectation. 5. Severe coagulation dysfunction. 6. Severe hypertension or ischemic heart disease and/or uncompensated diabetes mellitus proven through clinical examination. 7. Occurrence of congestive heart failure, myocardial stroke, angina or any in-course unstable arrhythmia, that has required medication. 8. Patients treated with immunotherapy over the last month (except Nimotuzumab®) or those that are receiving other type of specific oncological treatment over the last 15 days. 9. Patients that are participating or that recently participated (1 month) in another study, except for phase IV trials with Nimotuzumab®. 10. Sepsis of the Central Nervous System. 11. Severe psychiatric inconvenience or another limitation that impede the patient to give their consent or complicate its evaluation.
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