Administration of CIGB-247 in solid malignant tumors. Phase I study on scaling up dosages.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana.0 个研究点开始时间: 2011年4月29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: Other

•1) Fulfillment of diagnostic criteria (patients with histologically confirmed solid malignant tumor, from any location, advanced clinical stage, have received the best treatment available oncospecific, and have not responded to it). 2) Age between 18 - 65 years inclusive. 3) Patient with a life expectancy = 6 months. 4) According to ECOG performance status = 2. 5) Voluntariness of the patient by signing the informed consent.

•1) Uncompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2) Referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory properties. 3) History of autoimmune disease (lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and previous severe allergic (hives, dermatitis, bronchitis and bronchial asthma persistent). 4) Moderate or severe systemic infections that interfere with patient evaluation. 5) Patients who have received any investigational biologic therapy (a cancer vaccine), including active or passive immunotherapy. 6. Chemoradiotherapy have received in the last 4 weeks. 7. History of allergy to any component of the vaccine under study. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Obvious mental incapacity to give consent and act accordingly to the study.

发起方

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