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Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

dendritic cells, OK-432

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fukushima Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dendritic cells

Arm Description

Outcomes

Primary Outcome Measures

To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432

Secondary Outcome Measures

To determine the overall response rate for this regimen as determined by overall and disease-free survival.

To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells

Full Information

NCT ID

NCT00795977

First Posted

November 19, 2008

Last Updated

September 7, 2011

Sponsor

Fukushima Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00795977

Brief Title

Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2003 (undefined)

Primary Completion Date

November 2011 (Anticipated)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fukushima Medical University

4. Oversight

Data Monitoring Committee

5. Study Description

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 (OK-432) for patients with resectable pancreatic cancer for pancreatic cancer patients.

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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dendritic cells

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

dendritic cells, OK-432

Intervention Description

Single Group Assignment

Primary Outcome Measure Information:

Title

To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To determine the overall response rate for this regimen as determined by overall and disease-free survival.

Time Frame

2 years

Title

To evaluate the immune response of patients treated with this regimen based on the presence and characterization of tumor-infiltrating white blood cells

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitsukazu Gotoh, MD & PhD

Organizational Affiliation

Fukushima Medical University, Department of Surgery 1

Official's Role

Study Chair

Facility Information:

Facility Name

Fukushima Medical University Hospital

City

Fukushima

ZIP/Postal Code

960-1295

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

16309221

Citation

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.

Results Reference

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PubMed Identifier

8854822

Citation

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.

Results Reference

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PubMed Identifier

15289356

Citation

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.

Results Reference

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PubMed Identifier

15553710

Citation

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.

Results Reference

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Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

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