Preoperative Intratumor Dendritic Cells Injection Immunotherapy for Patients With Pancreatic Cancer

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795977

Enrollment

Registered

2008-11-21

Start date

2003-11-30

Completion date

2012-11-30

Last updated

2011-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

preoperative, intratumor, dendritic cells, pancreatic cancer, OK-432

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.

Interventions

BIOLOGICALdendritic cells, OK-432

Single Group Assignment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026