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Sponsored by: |
Fukushima Medical University |
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Information provided by: | Fukushima Medical University |
ClinicalTrials.gov Identifier: | NCT00795977 |
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 I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | November 2003 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
dendritic cells: Experimental |
Biological: dendritic cells, OK-432
Single Group Assignment
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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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Resectable pancreatic cancer without distant metastasis:
Exclusion Criteria:
Contact: Akira Kenjo, MD | +81-24-547-1254 | a-kenjo@fmu.ac.jp |
Japan | |
Fukushima Medical University Hospital | Recruiting |
Fukushima, Japan, 960-1295 | |
Contact: Akira Kenjo, MD +81-24-547-1254 a-kenjo@fmu.ac.jp | |
Principal Investigator: Akira Kenjo, MD |
Study Chair: | Mitsukazu Gotoh, MD & PhD | Fukushima Medical University, Department of Surgery 1 |
Responsible Party: | Fukushima Medical University ( Department of Surgery I ) |
Study ID Numbers: | 198 |
Study First Received: | November 19, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00795977 |
Health Authority: | Japan: Institutional Review Board |
preoperative intratumor dendritic cells pancreatic cancer OK-432 |
Digestive System Diseases Digestive System Neoplasms Pancreatic Neoplasms Picibanil Endocrine System Diseases |
Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |