Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT00795977
Verified September 2011 by Akira Kenjo, Fukushima Medical University. Recruitment status was: Active, not recruiting
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 (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.
Condition or disease
Biological: dendritic cells, OK-432
Phase 1Phase 2
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) immunotherapy is expected favorable outcome when it is approached directly to the cancer tissue. To evaluate safety and immunological responses, we conducted a phase I/II study of intra-tumor DCs immunotherapy for pancreatic cancer patients.
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Ages Eligible for Study:
20 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Active or uncontrolled infection
Active or uncontrolled other malignancy
Steroids or immunosuppressing agent dependant status
Decision of unsuitableness by principal investigator or physician-in-charge