lung carcinoma non small cell lung cancer
Conditions
Interventions
Patients will be given a subcutaneous injection of a vaccine consisting of 5
overlapping peptides covering the entire XAGE1B protein emulsified in Montanide
ISA 51 co-mixed with the adjuvant Hiltono
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For stage I&II pulmonary adenocarcinoma patients: * Histologically proven pulmonary adenocarcinoma stage I or II according to recent guidelines on TNM classification of NSCLC * Age * 18 years * Completion of curative resection or SBRT and adjuvant chemotherapy or radiotherapy if necessary according to guidelines. * Good WHO performance status (0-2) * Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L * Survival expectation > 3 months * Written informed consent according to the local Ethics Committee requirements;For stage III pulmonary adenocarcinoma patients:;* Histologically proven pulmonary adenocarcinoma stage IIIb according to recent guidelines on TNM classification of NSCLC. * Age * 18 years * Completion of standard chemo-radiotherapy * No intention for further chemotherapy treatment * Good WHO performance status (0-2) * Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L * Survival expectation > 3 months * Written informed consent according to the local Ethics Committee requirements;For stage IV pulmonary adenocarcinoma patients: * Histologically proven pulmonary adenocarcinoma stage IV according to recent guidelines on TNM classification of NSCLC 1. * Age * 18 years * Completion of standard (platinum-based) chemotherapy schedules with no intention for further chemotherapy treatment * Good WHO performance status (0-2) * Adequate bone marrow function: WBC * 2.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 5.0 mmol/L * Survival expectation > 3 months * Written informed consent according to the local Ethics Committee requirements
Exclusion criteria
Exclusion criteria: * Progressive disease after finishing standard treatment * Inadequate bone marrow function more than 3 weeks after last chemotherapy treatment. * Poor WHO performance status (3-5) * Eligibility for treatment with Tyrosine Kinase Inhibitors (e.g. erlotinib) * History of an autoimmune disease or other systemic intercurrent disease that might affect the immunocompetence of the patient, or patients receiving immunosuppressive therapy including transplant recipients * Second primary tumor of non-pulmonary origin * CD4 cell count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be assessed during the whole study by collecting all adverse events according to the CTC version 3 and by monitoring vital signs, blood chemistry and hematological parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological assessments will be performed in all vaccinated patients using a blood sample drawn at several time points (day 1, 22 and 43) and a skin biopsy of the last vaccination site. Immunological responses will be monitored using peripheral blood lymphocytes that are tested by IFN*-ELISPOT and intracellular IFN*/IL-2 staining for directly ex-vivo detection and enumeration of antigen-specific CD4+ and/or CD8+ T-cells, as well as following one round of in vitro stimulation. In addition, proliferation (lymphocyte stimulation test: LST) and associated cytokine production (IFN*, TNF*, IL-4, IL-5, IL-10, and IL-2) will be assessed. Furthermore, biopsy samples of the last vaccination site will be used to assess the migratory capacity of vaccine-induced T-cells. | — |
Countries
Netherlands
Outcome results
None listed