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Status unknownNCT00795977Updated Sep 8, 2011

Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

A Phase 1/2 interventional study of dendritic cells, OK-432 in Pancreatic Cancer, sponsored by Fukushima Medical University. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-09-08.

Sponsored by Fukushima Medical University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • preoperative
  • intratumor
  • dendritic cells
  • pancreatic cancer
  • OK-432
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
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

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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    dendritic cells

    Biological: dendritic cells, OK-432

Interventions

  • Biologicaldendritic cells, OK-432

    Single Group Assignment

05

What researchers measure

Primary outcomes

  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 outcomes

  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

06

Study locations

1 site
  • Fukushima Medical University Hospital
    Fukushima, 960-1295, Japan
07

References and documents

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. PubMed 16309221 ↗
  • 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. PubMed 8854822 ↗
  • 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. doi: 10.1158/0008-5472.CAN-03-4005. PubMed 15289356 ↗
  • 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. PubMed 15553710 ↗
08

Registry details

Key details

Study ID
NCT00795977
Lead sponsor
Fukushima Medical University
Responsible party
Akira Kenjo (Department of Surgery I, Fukushima Medical University) — Principal investigator
First posted
Nov 21, 2008
Start date
Nov 2003
Primary completion
Nov 2011 (estimated)
Completion
Nov 2012 (estimated)
Last update
Sep 8, 2011

Study contacts

Mitsukazu Gotoh, MD & PhD
study chair · Fukushima Medical University, Department of Surgery 1

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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