None listed
Conditions
Interventions
Drug : Dendritic Cell Inj. : - Dose: 1.2×107 cells, - Route: Intra dermal, - Time : 1cycle(D0), 2cycle(D14), 3cycle(D28), 4cycle(D56),
5cycle(D84)
cyclophosphamide : -Dose
Sponsors
Dongnam Institute of Radiological & Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men or women aged 20 years or older ? Patients with a histologically confirmed diagnosis of non-small cell lung cancer (AJCC TMN stage ?A–?A) who completed at least one round of postoperative adjuvant therapy *adjuvant therapy (chemotherapy: cisplatin/vinorelbine, radiotherapy) ? Patients with an autologous (frozen) tumor tissue sample for non-small cell lung cancer ? Patients with an ECOG score of 0–2 for performance status ? Patients satisfying the following conditions: - hematologic function: WBC count =4,000/µL, ANC =1,500/µL - platelet count =100,000/µL, hemoglobin =10 mg/dL - hepatic function: bilirubin =1.5-fold the normal values, ALT and AST =2.5-fold the normal values - renal function: creatinine =1.5 mg/dL ? Among fertile patients, individuals consenting to the use of appropriate contraception ? Among female patients who may be pregnant, patients with a negative result in urine HCG tests 7 days before registration ? Individuals who sign the consent form and are able to consent to the study and follow-up procedures
Exclusion criteria
Exclusion criteria: ? Patients who underwent other anticancer therapies excluding radiotherapy, but including immunotherapy or non-cisplatin/vinorelbine chemotherapy, before participating in the trial ? HIV-positive patients ? Patients for whom the planned dose of the test drug cannot be prepared because of the difficulty in obtaining a sufficient amount of autologous tumor tissue ? Patients with findings of autoimmune or inflammatory disease ? Patients with severe heart disease or internal disease ? Patients with central nervous system or psychiatric abnormalities ? Patients with findings of another malignant tumor ? Patients with an ongoing systemic disease (active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver disease, kidney disease, metabolic disease) ? Pregnant or breastfeeding women ? Patients who have received another test drug less than 4 weeks before the start of treatment with the current test drug ? Patients who have undergone other immunotherapy (excluding G-CSF) ? Patients who have received treatment for tuberculosis within the last year ? Patients who have been judged to be unsuitable as a clinical trial participant by another researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety(Adverse event and concomitant medication) | — |
Secondary
| Measure | Time frame |
|---|---|
| Examine the immune response;analyze survival (disease-free survival, overall survival) | — |
Countries
Korea, Republic of
Contacts
Public ContactMi young Kim
Dongnam Institute of Radiological & Medical Sciences
Outcome results
None listed