Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Fukushima Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Akira Kenjo, Fukushima Medical University
ClinicalTrials.gov Identifier:
NCT00795977
First received: November 19, 2008
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Pancreatic Cancer
Biological: dendritic cells, OK-432
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fukushima Medical University:

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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the overall response rate for this regimen as determined by overall and disease-free survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2003
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dendritic cells Biological: dendritic cells, OK-432
Single Group Assignment

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00795977

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

Publications:
Responsible Party: Akira Kenjo, Department of Surgery I, Fukushima Medical University
ClinicalTrials.gov Identifier: NCT00795977     History of Changes
Other Study ID Numbers: 198
Study First Received: November 19, 2008
Last Updated: September 7, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by Fukushima Medical University:
preoperative
intratumor
dendritic cells
pancreatic cancer
OK-432

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014