An Exploratory Trial To Evaluate Efficacy And Safety For Combination Treatment Of Adenovirus Double Suicide Gene Therapy

Study Overview

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

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.

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

Pancreas Cancer

DRUG: Theragene arm

SNUBH-IMGPB-2021-02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-02-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-03-15
First Submitted that Met QC Criteria 2021-02-01	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-03-17
First Posted (ACTUAL) 2021-02-04	Results First Posted N/A	Last Verified 2021-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Theragene arm Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy	DRUG: Theragene arm Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Theragene arm

Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and radiation therapy

DRUG: Theragene arm

Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Jin-Hyeok Hwang, MD PhD

Phone Number: +82-31-787-7017

Email: wooltong@snu.ac.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

NewGenPharm Incoporation

Investigators

PRINCIPAL_INVESTIGATOR: Jin-Hyeok Hwang, MD PhD, Seoul National University Bundang Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record