Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: dendritic cells, OK-432


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dendritic cells<br> | Biological: dendritic cells, OK-432<br>* Single Group Assignment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall response rate for this regimen as determined by overall and disease-free survival. |  | 2 years | 
| To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432