CENTAURO Study
- Conditions
- Solid malignant tumors.
- Registration Number
- RPCEC00000102
- 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
- Not specified
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method