Non-Small Cell Lung Cancer (NSCLC)
Conditions
Interventions
Study group (Vaccine): VAXIRA®. The patient will receive 1mg/dose by intradermal route. The first five doses every 14 days and every 28 days during two years. After that, the vaccine will be administe
Vaxira adjuvant
Sponsors
National Institute of Oncology and Radiobiology (INOR)
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1-Male and female patients = 18 years with tumors in non-small cell lung and pathologically proven completely resected stage IB, II or IIIA stages. 2-Patients who have signed informed consent for research. 3-Patients where surgical technique for tumor resection patient has been anatomical, involving at least a lobectomy . 4-Patients in the mediastinal lymph node sampling has been carried out by radical mediastinal lymphadenectomy corresponding compartment. 5-Disease-free patients (locoregional metastases or relapse), confirmed by a negative CT study at baseline chest CT scan, upper abdomen and brain CT or MRI. 6-Patients with performance status 0-2 according to ECOG scale. 7-Patients who received adjuvant chemotherapy after surgery, have been completed or not all cycles. 8-Patients who have then received adjuvant chemotherapy, radiotherapy treatment option in accordance with pN. 9-Patients in the time between the end of oncospecific treatment and inclusion in the study does not exceed 2 months. 10-Patients with hepatic, renal and haematological normal functions defined by: -Hemoglobina >= 10 g / L Leukocyte - Total count >= 3.0 x 109 / L Absolute Neutrophil -Count >= 1.5 x 109 / L Platelet -Count >=100 x 109 / L -Bilirubin To the upper limit of normal. -TGP And TGO: up 1.5 times the upper limit of 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- Stage IIIA patients who received neoadjuvant chemotherapy before surgery. 2- Patients whose primary tumor was removed by segmentectomy or wedge resection. 3- Patients showing any microscopic evidence of residual tumor after surgery (positive BSQ). 4- Patients who have previously received treatment with VAXIRA® vaccine or other immunotherapy. 5- Patients with previous history of cancer, except nonmelanoma skin tumors or carcinoma in situ of the cervix treated properly. 6- Patients with acute infectious diseases, chronic inflammatory or unbalanced. 7- Patients of childbearing age who do not accept use appropriate contraception (intrauterine devices, barrier methods or tubal ligation, hormonal methods). 8- Patients pregnant or breastfeeding. 9- Patients with acute allergic conditions or history of severe allergic reactions. 10- Patients who have received organ grafts. 11- Patients with psychiatric illness or addiction problems that may compromise their ability to give informed consent or to comply with trial procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS is defined as the time from randomization until recurrence of tumor or death from any cause). Measuring time: every 3 months during 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (Time from randomization until death from any cause). Measuring time: 5 years Adverse events (Description of any adverse event using CTCAE version 4). Measuring time: in every administration during 5 years. Quality of Live (Questionnaire developed by INOR: CV-INOR- 26-(V.01)). Measuring time: at baseline and every 3 months during 5 years. Immune response: antibody titers against neu GcGM3 (It will be positive when the inverse of the highest serum dilution giving optical density = 0.25 and twice the value of the pre-immune serum). Measuring time: at baseline and every 3 months during 5 years. Ability to lyse ganglioside expressing cells (It will be positive if percentage of dead cells =20 %, after subtracting the pre-immune to hyper-immune percent). Measuring time: at baseline and every 3 months during 5 years. | — |
Countries
Cuba
Contacts
Public ContactMaurenis Hernandez Perez
Center of Molecular Immunology
Outcome results
None listed