Evaluation of the Effectiveness and Safety of Monoclonal Antibody HR3(Nimotuzumab)for the treatment of patients with high grade glioma tumors.

Center of Molecular Immunology(CIM)0 个研究点开始时间: 2009年9月18日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Treatment

•1.Patients with glials tumors grade III or IV confirmed by pathology techniques,which at the time of inclusión are candidates for onco-specific treatment or patients with the same diagnosis who are relapsed.
•2.Age = 18 years of both sexes.
•3.General health status according to Karnofsky index = 50.
•4.Laboratory parameters within normal limits defined as:Hematopoietic:Hemoglobin = 9 g/L,total leukocytes count = 3 x 109 cells/L,platelets = 100 x 109/L Hepatic:hepatic function within 2.5 times upper limit of normal and without liver diseases demonstrated by TGP and TGO alkaline phosphatase.
•5.Patients express written voluntary entry into the study by signing the document informed consent.
•6.Patients of childbearing age should have a negative pregnancy test and used effective methods of contraception such as IUDs,hormonal contraceptives, barrier method or tubal ligation.

•1.Pregnancy or lactation.
•2.Patients with a concomitant second tumor.
•3.Submit a chronic disease associated in decompensated phase(heart disease,diabetes,hypertension).
•4.History of hypersensitivity to other similar product.
•5.Severe acute allergic states.
•7.Severe septic processes.

发起方

Center of Molecular Immunology(CIM)