Clinical Trial Phase I For Theragene In Combination With Chemotherapy For The Locally Advanced Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

BIOLOGICAL: Theragene®,Ad5-yCD/mutTKSR39rep-ADP

SNUBH-IMGPB-2016-02

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 2016-08-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-09-10
First Submitted that Met QC Criteria 2016-09-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-09-12
First Posted (ACTUAL) 2016-09-09	Results First Posted N/A	Last Verified 2019-08

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 chemotherapy	BIOLOGICAL: Theragene®,Ad5-yCD/mutTKSR39rep-ADP Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Theragene arm

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

BIOLOGICAL: Theragene®,Ad5-yCD/mutTKSR39rep-ADP

Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy

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

Secondary Outcome Measures	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

Contacts and Locations

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

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:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

NewGenPharm Inc.

Investigators

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

Lee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19.

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Resources

PatientS

Caregivers

Clinical Trial Record