Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer
- Conditions
- stage II-IIIA non-small cell lung cancer
- Registration Number
- JPRN-UMIN000010386
- Lead Sponsor
- ational Hospital Organization Kyushu Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease free survival at 2 years
- Secondary Outcome Measures
Name Time Method KT-specific immune response safety overall survival