Advanced non small cell lung cancer
Conditions
Interventions
Racotumomab group (experimental): Racotumomab therapeutic vaccine, 1 mg by intradermic route. The first 5 administration will be every 14 days (induction stage) and, the rest of vaccines will be admin
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1-Patients who meet the diagnostic criteria. 2-Patients older than or equal to 18 years old. 3-Patients who have signed the informed consent for the investigation. 4-Patients with clinical status according to ECOG from 0 to 2. 5-Patients who have received first-line treatment and reached at least stable disease in response. 6-Patients in which the time between the end of the onco-specific treatment and the inclusion in the study is 4 to 6 weeks. 7-Patients with life expectancy of six months or more. 8-Patients with normal hepatic, renal and hematological functions defined by: • Hemoglobin greater or equal to 90 g / L (patients with lower Hb levels should be transfused prior to inclusion) • Total Leukocyte Count greater or equal to 3.0 x 109 / L • Absolute Neutrophil Count greater or equal to 1.5 x 109 / L • Platelet Count greater or equal to 100 x 109 / L • Bilirubin up to the normal upper limit. • TGP and TGO: greater or equal to 1.5 times the upper limit for the normal value of the institution, or 50 mL / min / 1.73 m2 for patients with creatinine levels above the normal value of the institution.
Exclusion criteria
Exclusion criteria: 1-Patients who have previously received treatment with the anti-idiotypic vaccine Racotumomab. 2- Patients with acute, chronic, or inflammatory decompensated infectious diseases. 3- Patients of childbearing age who do not accept adequate contraceptive methods (intrauterine devices, barrier or tubal ligation methods, hormonal methods). 4- Pregnant or lactating patients. 5- Patients with acute allergic states or history of severe allergic reactions. 6- Patients who are receiving any other product under investigation. 7- Patients with brain metastasis. 8- Patient with other malignant diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Immunocompetence of patients (Frequency and phenotype of B lymphocytes, T and NK cells). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met. -Immune response (Title and functionality of antibodies induced by the vaccine). Measurement time: At baseline, at the end of the induction stage (day 84) and, every three months until the 15 doses are met. -Inhibition of tumor angiogenesis (Concentration of biomarkers related to angiogenesis and tumor inflammation: IL 8, VEGF, FGF, EGF, IL 6) Measurement time: At baseline, at the end of the induction stage ( day 84) and then every three months until the 15 doses -Overall Survival: (Time from recruitment until to death, from any cause). Measurement time: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory tests (numerical values of the Hemogram with differential, GPT, GOT, GGT, Alkaline Phosphatase, LDH, Creatinine, Glycemia). Measurement time: At baseline and, very three months until 24 months. | — |
Countries
Cuba
Contacts
Public ContactGeidy Lorenzo Monteagudo
Center of Molecular Immunology (CIM)
Outcome results
None listed