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Trial record 12 of 134 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT02894944
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
NewGenPharm Inc.
Information provided by (Responsible Party):
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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 :
  1. Number of participants with treatment-related adverse events assessed by CTCAE v4.03 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894944


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
NewGenPharm Inc.

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02894944     History of Changes
Other Study ID Numbers: SNUBH-IMGPB-2016-02
First Posted: September 9, 2016    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: August 2019
Keywords provided by Seoul National University Hospital:
Pancreatic cancer
Adenovirus
Gene therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases