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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Time frame: 8 weeks
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Time frame: 12 weeks
Tumor response
Time frame: 8 weeks
Time to disease progression
Time frame: 6.5 months
Detection of Infected Adenovirus in blood and urine assessed by PCR
Time frame: 8 weeks
Detection of adenoviral DNA in blood by PCR
Time frame: 8 weeks
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