unresectable pancreatic cancer
Conditions
Interventions
Gemcitabine 1,000 mg/m2/day day1,8,15 Dendritic cell day8,15 q4w , 3 cycle
Sponsors
School of Medicine, Keio University
Tokyo Midtown Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological diagnosis of pancreatic cancer 2)Cancer cells express WT1 3)Possess HLA-A2402 4)Patients don't have immediate allergy to WT1 peptide 5)Obtains lesion that can be evaluated by RECIST 6)Four weeks or more must pass from the prior treatment 7)performance status (ECOG) 0, 1 8)Adequate hematologic, hepatic, renal, and cardiac function a)WBC >=3,000/mm3 b)Absolute neutrophil count 1,500/mm3 c)Platelet >=100,000/mm3 d)Hemoglobin >=9.0g/dL e)AST and ALT <=150IU/L f)Total bilirubin <3.0mg/dL g)Creatinine <1.5mg/dL h)ECG normal 9)Patients expected of four months or more survival 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Active other primary malignancies 2)Past history of severe allergy 3)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes) 4)Pleural effusion or pericardial fluid requiring treatment 5)Pregnancy, nursing women 6)Male hope to impregnate 7)Carrier of HBV, HTLV-1, HIV and so on 8)Severe psychiatric disease 9)Symptomatic interstitial pneumonia or fibroid lung that be diagnosed by X-ray 10)Past history of autoimmune disease 11)During treatment with immunosuppressive agents 12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Progression free survival Overall survival Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide) | — |
Countries
Japan
Contacts
Public ContactMinoru Kitago
School of Medicine, Keio University Department of Surgery
Outcome results
None listed