Safety clinical trial and pharmacological evaluation of intravenous administration of CIGB-300 in patients with solid tumors refractory to oncospecific treatment.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点开始时间: 2011年5月16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: Other. Purpose: Treatment

•1) Histological diagnosis of a solid tumor refractory to treatment oncospecific. 2) That the patient did not receive more than 2 lines of chemotherapy. 3) last cycle of chemotherapy 4 to 8 weeks after treatment ends oncospecific. 4) Age between 18-75 years inclusive. 5) Written consent from the patient.

•1) Pregnancy and lactation 2) decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy, severe mental depression). 3) moderate or severe systemic infections that interfere with patient evaluation. 4) Patients with previous diagnosis of bleeding disorders and other chronic decompensated hematopatías (hemophilia, leukemia, etc.). 5) Values ??in clinical laboratory evaluations were normal limits prior to the start of treatment: 6) referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 7) Autoimmune diseases (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic urticaria, dermatitis, bronchitis, bronchial asthma and persistent. 8) diseases that compromise the patient's consciousness or his ability to give informed consent or cooperate in the trial. 9) Have been included in another trial in the last 8 weeks.

发起方

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.