Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer

Clinical Trial Phase I for Evaluation of Tolerability and Safety of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer

Pancreatic cancer is associated with an extremely poor prognosis, reflected by a 5-y survival probability of less than 5% when all stages are combined. At present, only approximately 10%-20% of patients are considered candidates for curative resection. The majority of patients (50%-60%) are present with metastatic disease, and substantial number of patients (approximately 30%-40%) are considered ''locally advanced'' at the time of diagnosis.

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed an anti-cancer effect in patients with prostatic cancer in phase I study. From the experience of prostatic cancer, the safety of combination with standard chemotherapy with Theragene treatment is assessed in this study.

Inclusion Criteria:

• Patients with pancreatic cancer stage 3
• Patients with histologically confirmed pancreatic adenocarcinoma
• Patients with no evidence of peritoneal or hematogenous metastasis
• Patients with ECOG performance status 0-2
• Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
• Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
• Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 2.5 times upper limit of normal (ULN))
• Patients with agreement with informed consent
• Male patients with contraception

Exclusion Criteria:

• Female patients with childbearing age or pregnancy or breast feeding
• Patients with a history of chemotherapy within 5 years
• Patients with a history of radiation on more than 25% of bone marrow
• Patients with unknown stage or recurrent pancreatic cancer
• Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer
• Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement
• Patients with active or uncontrolled infection
• Patients with immunosuppression or susceptibility to viral infection
• Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
• Patients with a history of allergy to clinical trial medications
• Patients who are considered as inappropriate candidate by investigators