Safety and immunogenicity of the CIGB-247 vaccine candidate combining different antigen doses with different amounts of VSSP adjuvant or with a fixed dose of aluminum phosphate in cancer patients.

Center for Genetic Engineering and Biotechnology (CIGB), in Havana0 个研究点目标入组 50 人开始时间: 2013年6月6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: Randomized controlled trial. Masking: Open. Control group: Dose comparison. Assignment: Parallel. Purpose: Treatment

•1) Fulfillment of diagnostic criteria (patients with histologically confirmed solid malignancy of selected locations, which are not eligible for other therapeutic regimens). 2) Age between 18 - 65 years inclusive. 3) Patient with a life expectancy = 6 months. 4) According to ECOG performance status = 2. 5) Primary tumor in any of the following locations: breast, lung, uterus (body), ovary, kidney, small intestine (duodenum, jejunum and ileum) or large (cecum, colon, rectum and anal canal), soft tissue and bone. 6) Patient with at least one measurable lesion according to RECIST. 7) Patients with stable or progressive disease at the time of study entry. 8) Voluntariness of the patient by signing the informed consent.

•1) Unknown primary tumor. 2) Patients who have received any anti-angiogenic treatment in the past 3 months. 3) Have received chemoradiotherapy in the last 4 weeks. 4) Major surgery in the last 28 days. 5) Referred immunosuppressive disease, current drug intake immunosuppressive / immunomodulatory. 6) Patients with brain metastases. 7) Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 8) History of autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, type 1 diabetes mellitus, etc.) and severe allergic history (urticaria, dermatitis, bronchitis and bronchial asthma persistent). 9) Moderate or severe systemic infections that interfere with patient evaluation. 10) History of allergy to any ingredient of the vaccine under study. 11) Patient pregnant or breastfeeding. 12) Mental incapacity to give consent obvious and act accordingly to the study.

发起方

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