pancreatic cancer, biliary cancer
Conditions
Interventions
Administer WT1 and MUC1 peptide-pulsed dendritic cell vaccination every 2weeks for a total of 7 times.
Sponsors
Nagasaki University Hospital
Tella, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Reveal of expression of WT1 for tumor cell from resected specimen 2) Administering of gemcitabine or S-1 as an adjuvant treatment after curative resection (treatment for preoperative is not considered) 3) HLA(HLA-A2402, HLA-A0201, HLA-A0206) of compatible types for WT1 peptide 4) Age between 20 to 80 years old 5) Performance status(ECOG) 0,1 6) Not be receiving any other clinical trial or investigational 7) Require initial protocol treatment within 12 weeks postoperatively 8) Tolerable cardiovascular system for apheresis to harvest peripheral-blood mononuclear 9) The ability to fully understand and sign a written informed consent for the clinical trial 10) Requiredment of following initial laboratory values within 14 days prior to registration WBC >=3,000/mm3 Absolute neutrophil count 1,500/mm3 Hemoglobin >=9.0g/dL Platelet >=100,000/mm3 Total bilirubin <1.5mg/dL AST <=100IU/mL ALT <=100IU/mL Creatinine <1.2mg/dL Creatinine clearance>=60mL/min 11) Negative reaction for hepatitis B virus antigen, hepatitis C virus, HTLV-1 and HIV
Exclusion criteria
Exclusion criteria: 1) Active primary malignancies 2) History of OK-432 and penicillin G allergy 3) Complication of uncontrolled hypertensionpiesia and diabetes 4) Unstable angina pectoris (within 3weeks) or cardiac infarct in past 6 months 5) Significant cardiac disease such as uncontrolled congestive heart failure or arrhythmia 6) Complication of pulmonary fibrosis, interstitial peumonia interstitial lung disease or double lung disease in the past or present. The same as the suspected disease from imaging findings 7) Bleeding peptic ulceration, intestinal paralysis or ileus 8) Taking immunosuppressive or corticosteroid (predonine or prednisolone 10mg for a day) 9) Pregnant and lactating women. Ineligible birth controlled men and women 10) Judged that have merged the mental disease or the neurological manifestation and the participation in this trial is difficult 11) Infant(under 20 years of age) 12) Inadequate for this study through doctor's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| relapse free survival antitumor immune response | — |
Countries
Japan
Contacts
Public ContactKazuhiro Nagai
Nagasaki University Hospital Transfusion and Cell Therapy Unit
Outcome results
None listed