This trial is active, not recruiting.

Condition pancreatic cancer
Treatment dendritic cells, ok-432
Phase phase 1/phase 2
Sponsor Fukushima Medical University
Start date November 2003
End date November 2011
Trial size 20 participants
Trial identifier NCT00795977, 198


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
dendritic cells, ok-432
Single Group Assignment

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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by Fukushima Medical University.