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NCT Number: NCT02894944

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.

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Key information

Conditions

Pancreatic Cancer Adenoviridae Infections DNA Virus Infections Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Infections Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Virus Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Bundang Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Theragene®,Ad5-yCD/mutTKSR39rep-ADP

Biological

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

Primary outcomes

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

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: 12 weeks

  2. Tumor response

    Time frame: 8 weeks

  3. Time to disease progression

    Time frame: 6.5 months

  4. Detection of Infected Adenovirus in blood and urine assessed by PCR

    Time frame: 8 weeks

  5. Detection of adenoviral DNA in blood by PCR

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • NewGenPharm Inc.

Registry information

Official study 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

Acronym: Theragene

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 9, 2016
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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