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

Seoul National University

Status and phase

Completed

Phase 1

Conditions

Pancreatic Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02894944

SNUBH-IMGPB-2016-02

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No 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