An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

Study Overview
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Brief Summary
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Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study. From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.

Detailed Description
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Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Official Title
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A Single Arm, Open, Exploratory Clinical Trial to Evaluate Efficacy and Safety for Combination Treatment of Replication Competent Adenovirus Double Suicide Gene Therapy(Theragene®,Ad5-yCD/mutTKSR39rep-ADP) and Radiation Therapy in Patients

Conditions
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Pancreas Cancer

Intervention / Treatment
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* Drug: Theragene arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with borderline resectable or locally advanced pancreatic cancer Patients with histologically confirmed pancreatic adenocarcinoma Patients with no evidence of peritoneal or hematogenous metastasis Patients with ECOG performance status 0-1 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 < 3 times upper limit of normal (ULN)) Patients with agreement with informed consent Exclusion Criteria: Patients with a history of other cancer Patients with recurred pancreatic cancer Patients with a history of radiation on more than 25% of bone marrow Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy Patients who have contraindication of radiation therapy Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis Female patients with childbearing age or pregnancy or breast feeding Patients who are considered as inappropriate candidate by investigators

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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 radiation therapy | Drug: Theragene arm<br>* Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | the proportion of patients with advanced or metastatic cancer who have achieved complete response or partial response | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate | the proportion of patients with advanced or metastatic cancer who have achieved complete response, partial response or stable disease | 24 weeks | 
| Tumor marker test | change of tumor marker in the process of assigned treatment | 24 weeks | 
| Overall survival | median time from beginning of treatment to death | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenovirus, pancreatic cancer, radiation therapy, gene therapy