Lung Cancer
Conditions
Interventions
Intervention group (VAXIRA®): 1mg, intradermic. Treatment duration: 15 doses, the first five immunizations will be administered every 14 days and the rest will be administered every 28 days during 1 y
Antibodies, Monoclonal, Humanized
Antibodies, Monoclonal
Drug Therapy
Administration, Intravenous
Nimotuzumab, VAXIRA
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 with tumor response (total or partial) or stable disease after the first line of oncospecific treatment. 3. Patients aged 18 or more. 4. Patients who have signed informed consent. 5. Serum EGF concentration 50 mL/min/1.73 m2 for patients with creatinine levels above normal values for the institution.
Exclusion criteria
Exclusion criteria: 1. Patients with previous history of use of anti idiotipic vaccine 1E10 and/or Nimotuzumab. 2. Patients carrying uncontrolled acute infectious diseases, chronic diseases, or inflammatory diseases. 3. Patients with fertile age who don’t accept to use proper anticonceptives methods (intrauterine devices, barrier methods or tubal ligation, hormonal methods). 4. Patients who are pregnant or breastfeeding. 5. Patients with acute allergic states or with history of severe allergic reaction. 6. Patients who are not tributary of oncospecific treatment. 7. Patients with brain metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (Time from randomization until death or date of last news). Measurement time: monthly for 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life (EORTC QLQ-C30 y QLQ-LC13). Measurement time: inclusion, every 3 months for a year. 2. Toxicity (Measurable by: occurrence of any AE (Yes/No)-Description of the AE (Name of the adverse event)-Duration of the AE (difference between the initial date and the termination date of the AE)-Intensity of the AE (1. Mild, 2. Moderate, 3. Severe, 4. Extremely severe, 5. Death)-Severity (1. Serious, 2. No serious)-Result (1. Recovered, 2. Enhanced, 3. Persists or Squeals)-Attitude towards treatment (1. Unchanged, 2. Dose modification, 3. Temporary interruption, 4. Definitive interruption)-Causality relationship (1. Very likely/sure/definitive, 2. Probable, 3. Possible, 4. Unlikely, 5. Not related, 6. Not evaluable/unclassified). Measurement time: monthly during 1 year. 3. Humoral Immune Response (measurable by: Ab response against VAXIRA (yes, no)-Response against NGGM3 (yes no)-Response against tumor antigens (yes/no; response-generating antigen). Measurement time: every three months for 1 year. 4. Cellular immune response (Measurable by: level of subpopulations (in %)-T lymphocyte mitogen activation capacity (in %). 5. Level of inflammatory cytokines: (in pg/mL). Measurement time: baseline and then every three months for 1 year. 6. Baseline EGF concentration (in pg/mL). Measurement time: baseline and then every three months for a year. 7. EGFR expression (Measurable by crosses: mild (+), moderate (++), high (+++), none (0). Measurement time: before starting treatment. 8. Biochemical parameters (measured by: hemoglobin (g/L)-leukogram with differential (cells/L), hematocrit (%)-platelets (-TOG (UI/L)-TGP-(UI/L)-bilirrubine (mg/dL)-glucose (mg/dL)-alkaline phostatase (UI/L), LDH (UI/L)-creatinine (mg/dL). Measurement time (baseline and then every three months for a year). 9. Objective Response (According to RECIST v. 1.1 criteria classified as Complete Response, Partial Response, Stable Disease, or Progressive disease). Measurement time: every three months | — |
Countries
Cuba
Contacts
Public ContactGeydi Lorenzo Monteagudo
Center of Molecular Immunology
Outcome results
None listed