Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

Fukushima Medical University20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

dendritic cells, OK-432BIOLOGICAL

Single Group Assignment

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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: 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

Locations (1)

Fukushima Medical University Hospital

Fukushima, Japan

Outcomes

Primary Outcomes

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

To determine the overall response rate for this regimen as determined by overall and disease-free survival.

Time frame: 2 years

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

Data from ClinicalTrials.gov

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