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Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00795977
Recruitment Status : Unknown
Verified September 2011 by Akira Kenjo, Fukushima Medical University.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2008
Last Update Posted : September 8, 2011
Information provided by (Responsible Party):
Akira Kenjo, Fukushima Medical University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: dendritic cells, OK-432 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2003
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: dendritic cells Biological: dendritic cells, OK-432
Single Group Assignment

Primary Outcome Measures :
  1. 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 Measures :
  1. To determine the overall response rate for this regimen as determined by overall and disease-free survival. [ Time Frame: 2 years ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00795977

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Fukushima Medical University Hospital
Fukushima, Japan, 960-1295
Sponsors and Collaborators
Fukushima Medical University
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Study Chair: Mitsukazu Gotoh, MD & PhD Fukushima Medical University, Department of Surgery 1

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Responsible Party: Akira Kenjo, Department of Surgery I, Fukushima Medical University Identifier: NCT00795977     History of Changes
Other Study ID Numbers: 198
First Posted: November 21, 2008    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Akira Kenjo, Fukushima Medical University:
dendritic cells
pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents