Unresectable non smaii cell lung cancer
Conditions
Interventions
Peptide vaccine plus Keppuchikuoto
Peptide vaccine
Sponsors
Kurume Unversity Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1) Cytologically or histologically documented non-small cell carcinoma of the lung that is not for curable therapy. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types. 4) Patients must be positive for HLA-A2,A24,A26,A3,A11,A31 or A33. 5) Patients must be expected to survive more than 3 months. 6) Ptient's laboratory data must satisgy the followings: WBC is more than 2500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dL Platelet is more than 80000/mm3 Serum Creatinine is less than 2 times the ULN Total bilirubin is less than 2 times the ULN 7) Patients must be more 18 year-old 8) Written informed consent must be obtained from patients.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with severe underlying diseases / conditions(active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiencies, disturbance of coagulation, et al. Respiratory diseases are pulmonary damage, such as interstitial pneumonia and pneumoconiosis). 2) Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3) Patients with the past history of severe allergic reactions. 4) (Females)Pregnant or nursing patients. Patients desiring future fertility. (Males)Patients who do not sccept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who has taken Keppuchikuoto. 6) Patients who has taken Bevacizumab.(Participation is made possible when four or more weeks have passed from the last medication to an examination opening day.) 7) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assesment of immunoresponses by mesurement of peptide specific CTL responses by ELISPOT assay | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assesment of immunoresponses by mesurement of peptide specific IgGs 2.Overall survival 3.Safety assesment | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactShigeru Yutani
Kurume University Cancer Vaccine Center
Outcome results
None listed