Preoperative Intratumor Dendritic Cells Injection Immunotherapy For Patients With Pancreatic Cancer

Study Overview

Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

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.

Pancreatic Cancer

BIOLOGICAL: dendritic cells, OK-432

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-11-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-09-07
First Submitted that Met QC Criteria 2008-11-20	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-09-08
First Posted (ESTIMATED) 2008-11-21	Results First Posted N/A	Last Verified 2011-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: dendritic cells	BIOLOGICAL: dendritic cells, OK-432 Single Group Assignment

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: dendritic cells

BIOLOGICAL: dendritic cells, OK-432

Single Group Assignment

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

100,000/mm3 T-Bil<2.0mg/dl BUN<25mg/dl, Creatinin<1.5mg/dl, 24h Ccr>50ml/min Normal ECG 3. Able and willing to give valid written informed consent
Exclusion Criteria:
1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 2. Breast-feeder 3. Active or uncontrolled infection 4. Active or uncontrolled other malignancy 5. Steroids or immunosuppressing agent dependant status 6. Interstitial pneumonia 7. Decision of unsuitableness by principal investigator or physician-in-charge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Mitsukazu Gotoh, MD & PhD, Fukushima Medical University, Department of Surgery 1

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kanzaki N, Terashima M, Kashimura S, Hoshino M, Ohtani S, Matsuyama S, Hoshino Y, Kogure M, Oshibe I, Endo H, Saito T, Yaginuma H, Gotoh M, Ohto H. Understanding the response of dendritic cells to activation by streptococcal preparation OK-432. Anticancer Res. 2005 Nov-Dec;25(6B):4231-8.
Takekuni K, Sakon M, Kishimoto S, Amano M, Sekimoto M, Aoki T, Oosato H, Dohno K, Umeshita K, Gotoh M, Monden T, Monden M. [A patient with unresectable cancer of pancreas head, effectively treated by a local injection of the mixture of OK-432, fibrinogen and thrombin]. Gan To Kagaku Ryoho. 1996 Sep;23(11):1621-3. Japanese.
Okamoto M, Furuichi S, Nishioka Y, Oshikawa T, Tano T, Ahmed SU, Takeda K, Akira S, Ryoma Y, Moriya Y, Saito M, Sone S, Sato M. Expression of toll-like receptor 4 on dendritic cells is significant for anticancer effect of dendritic cell-based immunotherapy in combination with an active component of OK-432, a streptococcal preparation. Cancer Res. 2004 Aug 1;64(15):5461-70. doi: 10.1158/0008-5472.CAN-03-4005.
Oshikawa T, Okamoto M, Ahmed SU, Tano T, Yoshida H, Sato M. [Anti-cancer effect of an intratumoral injection of dendritic cells expressing TLR4 in combination with an active component of OK-432 in TLR4-deficient mice]. Gan To Kagaku Ryoho. 2004 Oct;31(11):1770-2. Japanese.

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