Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

NCT ID: NCT00795977

Last Updated: 2011-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2012-11-30

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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dendritic cells

Group Type EXPERIMENTAL

dendritic cells, OK-432

Intervention Type BIOLOGICAL

Single Group Assignment

Interventions

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dendritic cells, OK-432

Single Group Assignment

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Resectable pancreatic cancer without distant metastasis:

1. ECOG performance status 0-2
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
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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fukushima Medical University

OTHER

Sponsor Role lead

Responsible Party

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Akira Kenjo

Department of Surgery I

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitsukazu Gotoh, MD & PhD

Role: STUDY_CHAIR

Fukushima Medical University, Department of Surgery 1

Locations

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Fukushima Medical University Hospital

Fukushima, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 16309221 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8854822 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15289356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15553710 (View on PubMed)

Other Identifiers

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198

Identifier Type: -

Identifier Source: org_study_id

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