NCT02894944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

September 12, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

August 10, 2016

Last Update Submit

September 10, 2019

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancerAdenovirusGene therapy

Outcome Measures

Primary Outcomes (1)

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

    8 weeks

Secondary Outcomes (5)

  • 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

Study Arms (1)

Theragene arm

EXPERIMENTAL

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

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

Interventions

Theragene®,Ad5-yCD/mutTKSR39rep-ADPBIOLOGICAL

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

Theragene arm

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32084409DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsAdenoviridae Infections

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

September 9, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2018

Study Completion

April 1, 2019

Last Updated

September 12, 2019

Record last verified: 2019-08

Locations

KR(1)