CIGB-247 vaccine in patients with solid malignant tumors, phase I, randomized. (CENTAURO-2 study)
- Conditions
- Solid malignant tumors.
- Registration Number
- RPCEC00000155
- Lead Sponsor
- Center for Genetic Engineering and Biotechnology (CIGB), in Havana
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Adverse Events (AE). Measuring time: in each immunization and at weeks 12,13 and 16. -Apearence of EA (Yes, No) -Description of EA (name of the event) -Intensity of EA (mild, moderate, severe). Laboratory tests (numerical values of hematology, biochemistry and urine). Measuring time: at weeks 1, 5, 9, 13 and 16.
- Secondary Outcome Measures
Name Time Method Immune response(determination of serum titers of anti-VEGF; percent of inhibition - binding VEGF and its receptor; ELISPOT for interferon gamma: average number of points). Measuring time: in weeks 1, 5, 9, 13 and 16. Quality of life (questionnaire EORTC QLQ-C30: worse, unchanged, slightly improved, moderately improved, much improved). Measuring time: in weeks 16. Tumor Response Assessment (tumor diameter). Measuring time: at week 16.