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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the maximally tolerated dose (MTD) and dose limiting toxicities (DLT) of intratumoral autologous dendritic cell vaccination in combination with OK-432
2 years
Yes
Mitsukazu Gotoh, MD & PhD
Study Chair
Fukushima Medical University, Department of Surgery 1
Japan: Institutional Review Board
198
NCT00795977
November 2003
November 2012
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