Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer - Full Text View

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

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:

ECOG performance status 0-2
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
Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
Breast-feeder
Active or uncontrolled infection
Active or uncontrolled other malignancy
Steroids or immunosuppressing agent dependant status
Interstitial pneumonia
Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

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:

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.

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.

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.

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.

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
Picibanil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013