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

March 15, 2021 updated by: Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

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

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital

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.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Collaborators

NewGenPharm Incoporation

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 Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

February 1, 2024

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH-IMGPB-2021-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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