Patients with completely resected stage II or IIIA non-small cell lung cancer followed by adjuvant c
Conditions
Interventions
Group A: intravenous administration of alpha-GalCel pulsed dendritic cells on day7, 14, 49 and 56.
Group B:no treatment with alpha-GalCel pulsed dendritic cells.
Sponsors
Saka Hideo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients for whom non-small cell lung cancer is confirmed histologically 2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node 3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.) 4) The pathological stage is IIA, IIB, IIIA. 5) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old. 6) no recurrence at the time of enrollment 7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1. 8) Trial treatment can be started within 4 to 16 weeks after 3-4 cycles of adjuvant chemotherapy with cisplatin and vinorelbine. 9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.) *Neutrophil count >=3,000/mm3 *Platelet count >=75,000/mm3 *Hemoglobin concentration>=9 g/dL *Serum creatinine =93% 10) NKT cells are detected at least 10 cells in 1 ml of peripheral blood. 11) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.
Exclusion criteria
Exclusion criteria: 1) Serious concomitant disease including severe infectious disease or malnutrition. 2) Postoperative pleural effusion or ascites or cardiac effusion which need to be controlled. 3) The patient who have simultaneous malignancy or who have metachronous malignancy within 5 years-disease free interval. 4) Concurrent corticosteroid therapy 5)Autoimmune disease 6) History of hepatitis 7) Positive response to HIV, hepatitis C virus or human T cell lymphotrophic virus antibodies or those with HBs antigen. 8) Severe cardiac disease(NYHA class III or IV) or severe pulmonary disease (greater than Hugh-Jones Classification III) 9) History of hyper-reactivity to albmin 10) Pregnancy or lactation 11) Contraindication to apheresis (angina, greater than atrioventricular block 2 degree, WPW syndrome, complete left bundle branch block, systolic blood pressure with 90 Torr or greater than 170 Torr) 12) The patients have been judged to be inappropriate to participate in this study by principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease free survival at 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| NKT-specific immune response, safety, overall survival | — |
Countries
Japan
Contacts
Public ContactTakahiro Kobayashi
National Hospital Organization Nagoya Medical Center
Outcome results
None listed