pancreatic and biliary tumors
Conditions
Interventions
Administration of Gemcitabine Gemcitabine (1000mg/m2 ) is administered via intravenous injection over 30min on day 1, 8, 15 of a 28-day cycle twice. Dendritic cell pulsed WT1 peptide vaccination T
Sponsors
Department of Internal medicine, Division of Gastroenterology and Hepatology, Kashiwa Hospital, Jikei University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as pancreatic or biliary cancer. 2. Informed about hisdiagnosis 3. 1) First-line treatment for inoperable patients. Stage IVa, IVb 2) Relapse after operation Initial chemotherapy Two months after last chemotherapy 4. HLA-A*2402, 0201, 0206, DRB1*0405, DRB1*0803, DRB1*1502, DRB1*1501, DPB1*0901, or DPB1*0501 positive 5. Having evaluable disease by RECIST criteria 6. No chemotherapy/radiation/BRM has been performed. 7. Karnofsky Performance Status (KPS) over 50 8. Survival period is expected more than 3 months 9. Meet the following criteria for organ functions 1) WBC more than 4,000/microliter and less than 12,000, Neutrophil more than 2,000/microliter, Platelet more than 100,000/microliter, Hemoglobin more than 9.5 g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than1.5 folds of the upper normal limit 4) Serum AST/ALT less than 2.5 folds of the upper normal limit 5) Serum Albumin more than 3.0g/dl 10. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells. 11. Pleural effusion, ascites and pericardial effusion are not detected. 12. Informed consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. There is deep-seated active infection. 2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered in appropriate for the trial. 4. Dependent on total parenteral nutrition (TPN). 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndrome (MDS) and myeloproliferative disorders (MDP). 7. Pregnant or lactating woman. 8. Past history of severe drug allergy. 9. There is severe psychiatric disease. 10. Responsible doctor's judged the patient inappropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical response rate Disease control rate Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1 | — |
Countries
Japan
Contacts
Public ContactKoido Shigeo
Jikei University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed