Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

Phase 1

• Conditions: Pancreatic Cancer
• Interventions: Biological: dendritic cells, OK-432

• Registration Number: NCT00795977
• Lead Sponsor: Fukushima Medical University

Brief 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.

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.

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-07
• Last Update Posted: 2011-09-08
• Primary Completion: 2011-11
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dendritic cells	dendritic cells, OK-432	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To determine the overall response rate for this regimen as determined by overall and disease-free survival.	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	2 years

Trial Locations

Locations (1)

Fukushima Medical University Hospital; 🇯🇵 Fukushima, Japan