Malignant tumors
Conditions
Interventions
Group I (experimental): CIGB 370 at dose of 1.85mg/m2. The product will administer at intravenously infused over 1 hour, twice a week for 4 weeks (8 administrations in total).
Group II (experimental):
Peptides
polypeptide, CIGB-370
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Compliance with the diagnostic criteria (histological diagnosis of a malignant tumor from any location, solid or hematopoietic, advanced clinical stage, they are not eligible for other therapeutic procedures). 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. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2. Moderate or severe systemic infections that interfere with patient evaluation. 3. Have received chemoradiotherapy in the past 4 weeks. 4. Patients who have received any investigational biological therapy or are involved in a clinical trial. 5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma). 6. History of cancer in situ of the uterine cervix. 7. History of allergy to any ingredient of the product under consideration. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Mental incapacity evident to issue consent and act accordingly to the study. 1. Decompensated chronic diseases (hypertension, diabetes mellitus, chronic renal failure, heart failure, hyperthyroidism, epilepsy). 2. Moderate or severe systemic infections that interfere with patient evaluation. 3. Have received chemoradiotherapy in the past 4 weeks. 4. Patients who have received any investigational biological therapy or are involved in a clinical trial. 5. History of chronic liver disease (chronic hepatitis, liver cirrhosis and hepatocellular carcinoma). 6. History of cancer in situ of the uterine cervix. 7. History of allergy to any ingredient of the product under consideration. 8. Pregnancy or breastfeeding at the time of inclusion in the study. 9. Mental incapacity evident to issue consent and act accordingly to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Adverse Events (AE). Measuring time: week 1, when initiating the administration of anti-tumor candidate CIGB-370, before each administration (during the first 4 weeks of treatment) and at weeks 5 to 8. The adverse events will be measured like: -Appearance of AE (Yes, No) -Description of AE (name of the event) -Intensity of EA (mild, moderate, severe) Laboratory tests (numerical values of hematology and biochemistry). Measuring time: at baseline, week 5, and week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of CIGB-370 polypeptide (i n serum). Measuring time: before administration CIGB-370, at 15 and 30 minutes post-infusion i n hours 1, 2, 3, 5, 7, 12, 16, 24, 36 and 48, and on days 7, 15, 21 and 28 post-treatment initiation. Immune response (titer determination of anti-bodies anti -CIGB370). Measuring time: Days 7, 15, 21 and 28. Identifying target polypeptide CIGB-370 tumor markers (plasma, qualitatively by co-immunoprecipitation method). Measuring time: at baseline, week 8. Quality of life (EORTC QLQ-C30 survey: worsened, unchanged, slightly improved, moderately improved, and much improved). Measuring time: at baseline, week 8. Tumor response (RECIST version 1.1: Complete response, Partial response, Stable Disease, Progressive disease). Measuring time: week 8. | — |
Countries
Cuba
Contacts
Public ContactIdania Baladrón Castrillo
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed