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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Theragene arm<br>Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy | Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP<br>* Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events assessed by CTCAE v4.03 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Adenovirus, Gene therapy