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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Theragene arm

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

Group Type EXPERIMENTAL

Theragene®,Ad5-yCD/mutTKSR39rep-ADP

Intervention Type BIOLOGICAL

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

Interventions

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Theragene®,Ad5-yCD/mutTKSR39rep-ADP

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No