imotuzumab for the treatment of high grade of malignancy tumors. Study of safety and effectiveness.

Center of Molecular Immunology(CIM)0 个研究点开始时间: 2013年2月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1.Patients with tumors glial with high-grade malignancy confirmed by pathology techniques, at the time of the inclusion in the trial, are candidates for treatment oncoespecifico or patients with the same diagnosis found in relapse, confirmed by pathology or Imaging. 2.Patients with age = 18 years of either sex. 3.General State of health according to Karnofsky index = 50%. 4.Laboratory parameters within the limits normal defined as: Hematopoietic: Hemoglobin = 9 g/l, total leukocytes = 3 x 109 cells/L, platelets = 100 x 109/l. Hepaticos: TGP/TGO and alkaline phosphatase up to 2.5 times upper limit of normal. 5.Patients expressed by voluntariness to participate in the study and informed consent signature. 6.Female patients in childbearing age who possess a negative pregnancy test and/or use effective contraception(intrauterine devices,hormonal contraceptives, tubal ligation or barrier method)in the case of male (vasectomy, condom use) prior to its inclusion and/or during your participation in the study.

•1.Pregnancy or breastfeeding. 2.A second concomitant tumour patients. 3.Presence of decompensated associated chronic disease (heart disease, diabetes, hypertension). 4.A history of hypersensitivity to recombinant proteins. 5.Acute and severe allergic states. 6.Febrile states. 7.Acute septic processes. 8.Treatment with nimotuzumab 6 months prior to the inclusion.

发起方

Center of Molecular Immunology(CIM)