Clinical trial NCT04739046: An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreas Cancer
Keywords: pancreatic cancer
radiation therapy
adenovirus
gene therapy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: NewGenPharm Incoporation
First posted: 2021-02-04
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 24 weeks
Secondary outcomes:
measure: Disease control rate
timeFrame: 24 weeks
measure: Tumor marker test
timeFrame: 24 weeks
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin-Hyeok Hwang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: