We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Akira Kenjo, Fukushima Medical University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795977
First Posted: November 21, 2008
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Akira Kenjo, Fukushima Medical University
  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: 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

Resource links provided by NLM:


Further study details as provided by Akira Kenjo, 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 ]

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 19, 2008
First Posted: November 21, 2008
Last Update Posted: October 12, 2017
Last Verified: September 2011

Keywords provided by Akira Kenjo, 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
Picibanil
Antineoplastic Agents