Solid malignant tumors.
Conditions
Interventions
The product is administered repeated doses subcutaneously in the deltoid region of arm less skillful, in three antigen dose levels: 50, 100 and 400 µg antigen p64K-hVEGFKDR-. The amount of adjuvant (V
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
Not aplicable
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the vaccine candidate CIGB-247, for which the record the following parameters: a) Clinical adverse events (Event Number, Type and Frequency: Yes, No, intensity: mild, moderate, severe). Measuring time: a week after each of the first 8 immunizations and at weeks 12 (re-immunization), 13 and 16 (one week and one month after vaccination booster), but also at other times it is presented some adverse event. b) Laboratory tests (valores numéricos de pruebas hematology and biochemistry). Measuring time: at weeks 1, 7, 12, 13 and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response to the vaccine (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, 7, 9, 12, 13 and 16. Quality of life of patients by applying the questionnaire EORTC QLQ-C30 (worse, unchanged, slightly improved, moderately improved, much improved). Measuring time: in weeks 9 and 16. Tumor Response Assessment, if applicable (tumor diameter). Measuring time: at week 16. Ophthalmologic evaluation, if applicable (visual acuity, contrast sensitivity, fundus, retinal sensitivity, optical coherence tomography). Measuring time: at week 13. | — |
Countries
Cuba
Contacts
Public ContactDr. Francisco Hernández Bernal
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed