Lung cancer
Conditions
Interventions
CIMAvax®-EGF. 2.4 mg per dose. The first 4 doses will be administered every 14 days and the remaining 4 doses, every 28 days until reaching 8 doses. The duration of the treatment will be 6 months. The
Immunotherapy, Active
Epidermal Growth Factor
Injections, Intramuscular
CIMAvax-EGF.
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria according to the cohort to which they belong. 2. Patients aged = 18 years for survivors of lung cancer and between 50 and 79 years for patients at high risk of lung cancer. 3. Patients who do not have imaging evidence of lung cancer, evaluated by CT according to RECIST criteria. 4. Patients of childbearing age who consent to the use of appropriate contraceptive methods (for example, hormonal or barrier contraceptive methods, withdrawal) before being included in the study. If a woman becomes pregnant or suspects that she is pregnant while she or her partner is participating in this study, she should inform her doctor immediately. 5. Patients who give their informed consent to participate in writing. In addition to the above criteria, patients must meet the following specific criteria of the cohort in which they will be included: Patients at high risk of lung cancer (Cohort A). 1. Document the presence of any of these risk factors • Moderate or severe COPD. • Family history of lung cancer. • Low body mass index. • Recent pneumonia. 2. Have quit smoking in the last 10 years or be a current smoker. 3. Have a history of smoking at least 50 packages / year. 4. Have the lung function test in the last 3 months before inclusion. Survivors of early stage lung cancer (Cohort B). 1. Having completed 3 months before inclusion, adjuvant therapy for lung cancer after surgery, with no evidence of early disease progression. 2. CPCNP confirmed in stage IB to IIIA in the initial diagnosis (TNM 8th edition).
Exclusion criteria
Exclusion criteria: 1. Patients not clinically fit to undergo the bronchoscopy procedure. 2. Patients with uncontrolled intercurrent diseases that include, among others, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia. 3. Patients with stage IIIA who are not surgical. 4. Patients with mild or very severe COPD. 5. Patients with psychiatric illness and / or social situations that would limit compliance with the study requirements. 6. Pregnant or breastfeeding patients. 7. Patients with another malignant disease in the previous 5 years, except skin cancer (not melanoma). 8. Patients who have received another product under investigation within 30 days prior to inclusion. 9. Patients who have received treatment for their disease with immunotherapy. 10. Patients with known immunosuppressive disease (for example, HIV, AIDS or other immunosuppressive disease). The test is not mandatory. 11. Patients with known hypersensitivity to the vaccine components under study or any analogue. 12. Patients requiring steroid treatment equivalent to doses greater than 20 mg of prednisone daily. 13. Patients reluctant or unable to follow the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.EGF concentration (The concentration of EGF in patients' blood will be determined in pg / mL). Time of measurement: At baseline, at 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and at 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine). 2.Anti-EGF antibody titers (In each patient the antibody titres will be determined in response to short-term vaccination and it will be determined if it is = 1: 4000). Time of measurment: At baseline, 14 days (+3) after the end of the induction phase (4th dose of the vaccine) and, 14 days (+3) of the evaluation at the end of the treatment under study (8th dose of the vaccine). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum IL-6 concentration (pg / ml). Measurement time: At baseline and, weeks 8 and 24. 2. Total bilirubin (mg / dL). Measurement time: At baseline and, weeks 8 and 24. 3. Neutrophil / lymphocyte ratio (neutrophil / lymphocyte ratio). Measurement time: At baseline and, weeks 8 and 24. 4. Platelet / lymphocyte ratio (platelet / lymphocyte ratio). Measurement time: At baseline and, weeks 8 and 24. 5. Myeloid suppressor cell frequency (MDSC) (%). Measurement time: At baseline and, weeks 8 and 24. 6. Absolute count and frequency of CD4 + T cells (total and %). Measurement time: At baseline and, weeks 8 and 24. 7. Absolute count and frequency of CD8 + T cells (total and %). Measurement time: At baseline and, weeks 8 and 24. 8. CD8 + CD28- T cell frequency (%). Measurement time: At baseline and, weeks 8 and 24. 9. CD4 / CD8 Index (CD4 / CD8 Ratio). Measurement time: At baseline and, weeks 8 and 24. 10. Grade 3, 4 or 5 toxicity attributable to the therapeutic vaccine CIMAvax®-EGF (The occurrence of Adverse events intensity grade 3 (severe), 4 (severe threatening or disabling) or 5 (severe that causes death will be evaluated in each patient) that is attributable (definitive, very probable, probable, possible) to the therapeutic vaccine CIMAvax®-EGF). Measurement time: Weeks 0, 2, 4, 6, 8, 10, 14, 18, 22, 24 and 30. 11. Adverse events-AE (Occurrence of some AE (Yes, No), Type of AE (according to the CTC version 5), Duration of the EA (Time between the start and end dates of the AE), AE intensity (Light, Moderate, Severe, Serious that threatens or incapacitates, Serious that produces death according to CTC version 5.0), Causality of AE (Definitive, Highly probable, Probable, Possible, Unrelated, Unknown), Severity of AE (Yes, No. In case of severity it will be classified according to the categories of: causes the death of the patient, threatens life, requires hospitalization or prolongs an existing hospitalization, produces a disability, significant or persistent disabilit | — |
Countries
Cuba
Contacts
Public ContactOrestes Santos Morales
Center of Molecular Immunology
Outcome results
None listed