Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Adenovirus, Gene therapy
Brief summary
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.
Interventions
BIOLOGICALTheragene®,Ad5-yCD/mutTKSR39rep-ADP
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Sponsors
NewGenPharm Inc.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03 | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03 | 12 weeks |
| Tumor response | 8 weeks |
| Time to disease progression | 6.5 months |
| Detection of Infected Adenovirus in blood and urine assessed by PCR | 8 weeks |
| Detection of adenoviral DNA in blood by PCR | 8 weeks |
Countries
South Korea
Outcome results
None listed