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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic cancer, Adenovirus, Gene therapy

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Theragene arm

Arm Description

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events assessed by CTCAE v4.03

Secondary Outcome Measures

Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Tumor response
Time to disease progression
Detection of Infected Adenovirus in blood and urine assessed by PCR
Detection of adenoviral DNA in blood by PCR

Full Information

First Posted
August 10, 2016
Last Updated
September 10, 2019
Sponsor
Seoul National University Hospital
Collaborators
NewGenPharm Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02894944
Brief Title
Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Acronym
Theragene
Official Title
Clinical Trial Phase I for Evaluation of Tolerability and Safety of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
NewGenPharm Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic cancer, Adenovirus, Gene therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theragene arm
Arm Type
Experimental
Arm Description
Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy
Intervention Type
Biological
Intervention Name(s)
Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Intervention Description
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by CTCAE v4.03
Time Frame
12 weeks
Title
Tumor response
Time Frame
8 weeks
Title
Time to disease progression
Time Frame
6.5 months
Title
Detection of Infected Adenovirus in blood and urine assessed by PCR
Time Frame
8 weeks
Title
Detection of adenoviral DNA in blood by PCR
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32084409
Citation
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.
Results Reference
derived

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

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