Title
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
Phase
Phase 1Lead Sponsor
Seoul National UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Pancreatic CancerIntervention/Treatment
ad5-ycd/muttksr39rep-adp ...Study Participants
9Pancreatic 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.
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy
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