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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


Phase 1/Phase 2
20 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

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


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.


Inclusion Criteria:



Resectable pancreatic cancer without distant metastasis:

1. ECOG performance status 0-2

2. Laboratory values as follows 3,500/mm3 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Mitsukazu Gotoh, MD & PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fukushima Medical University, Department of Surgery 1

Authority:

Japan: Institutional Review Board

Study ID:

198

NCT ID:

NCT00795977

Start Date:

November 2003

Completion Date:

November 2012

Related Keywords:

  • Pancreatic Cancer
  • preoperative
  • intratumor
  • dendritic cells
  • pancreatic cancer
  • OK-432
  • Pancreatic Neoplasms

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