Status:
UNKNOWN
Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer
Lead Sponsor:
Fukushima Medical University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to confirm safety and immunological responses of Preoperative intratumor dendritic cells injection immunotherapy using immature dendritic cells with S pyogenes Preparation...
Detailed Description
The prognosis of pancreatic cancer is extremely poor even with extensive surgery, and development of new treatment modalities is much-expected for cure of this disease. Dendritic cells (DCs) immunothe...
Eligibility Criteria
Inclusion
- Resectable pancreatic cancer without distant metastasis:
- ECOG performance status 0-2
- Laboratory values as follows 3,500/mm3 \<WBC\<12000/mm3 Platelet count\>100,000/mm3 T-Bil\<2.0mg/dl BUN\<25mg/dl, Creatinin\<1.5mg/dl, 24h Ccr\>50ml/min Normal ECG
- Able and willing to give valid written informed consent
Exclusion
- Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
- Breast-feeder
- Active or uncontrolled infection
- Active or uncontrolled other malignancy
- Steroids or immunosuppressing agent dependant status
- Interstitial pneumonia
- Decision of unsuitableness by principal investigator or physician-in-charge
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00795977
Start Date
November 1 2003
End Date
November 1 2012
Last Update
September 8 2011
Active Locations (1)
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1
Fukushima Medical University Hospital
Fukushima, Japan, 960-1295