Pancreatic cancer
Conditions
Interventions
Combination of 8 weeks of WT1 peptide vaccine with concurrent chemotherapy
Sponsors
Tohoku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients witth advanced or recurrent pancreatic cancer that is progressive with standard chemotherapy. Any regimen of prior chemotherapy is acceptalble. 2) Pancreatic cancer should be histologically confirmed and informed to the patient. 3) Patients with HLA-A2402. 4) Any prior surgical treatment, chemotheraphy, radiation therapy, immunotherapy other than WT1 is acceptable. 5) There should be at least two weeks from thea last chemotherapeutic administration. 6) Patients with measreable disease acccording to the RECIST criteria. 7) Patints should be 20-years-old or older and less than 80-years-old. 8) Patients with Karnofsky Performance status of 50 or more. 9) Patients whose survival is expected 3 months or longer. 10) Patients with organ function preserved as indecated below. WBC >= 3,000/microL and <12,000/microL Neutrophil >= 1,500/microL Platelets >= 50,000/microL Hemoglobin >= 9.0g/dL AST(GOT), ALT(GPT) < 5x Institutional upper limit. Total bilirubin <5x Institutional upper limit. Alubumin >= 2.5g/dL Creatinin < Instititional Upper Limit 11) Patients with written informed consent on this pilot study.
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrollable infection including active tuberculosis. 2) Patients with severe concurrent disease including malignant hypertension, congestive heart failure, severe coronary disorder, myocardial infarction within 3 months, severe liver cirrhosis, uncontrollable diabetes mellitus, lung fibrosis, interstitial pneumonia, prominent peripheral edeme. 3) Patients who showed severe complication (Grade 3 or more severe according to CTCAE version 3.0) with prior chemotherapy. 4) Patients who require 24 h or more intravenous, transcatheteric nutrition or total parenteral nutrition due to GI symptom. 5) Patients with double cancer. 6) Patients with myelo-dysplastic syndrome or myeopoliferative disease. 7) Pregnant or supposed to be pregnant patient. 8) Patients with past history of severe drug allergy. 9) Patients with severe mental disorder. 10) Patients who is not recommended by attending physician, or trial conductor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safty and toxicity Tumor response (Disease control) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immune response | — |
Countries
Japan
Contacts
Public ContactShinichi Egawa
Tohoku University Hospital Division of Hepato-Biliary-Pancreatic Surgery
Outcome results
None listed