Trial | NCT00795977  Report issue

Title

Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer
Phase I/II Study on Intratumor Dendritic Cell Injection Immunotherapy Using Immature Dendritic Cells With S Pyogenes Preparation (OK-432) for Patients With Resectable Pancreatic Cancer

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
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.
Study Started
Nov 30
2003
Primary Completion
Nov 30
2011
Anticipated
Study Completion
Nov 30
2012
Anticipated
Last Update
Sep 08
2011
Estimate

Biological dendritic cells, OK-432

Single Group Assignment

dendritic cells Experimental

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted