An Exploratory Trial to Evaluate Efficacy and Safety for Combination Treatment of Adenovirus Double Suicide Gene Therapy

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Pancreas Cancer

Treatments: Drug: Theragene arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04739046

SNUBH-IMGPB-2021-02

Details and patient eligibility

About

Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) showed safety and anti-cancer effect in patients with pancreatic cancer in phase I study.

From the experience of phase I study, the safety and efficacy of combination with standard chemotherapy and radiation therapy with Theragene treatment will be assessed in this study.

Full description

Phase IIa study of Replication-competent Adenovirus-mediated Double Suicide Gene Therapy (Theragene®,Ad5-yCD/mutTKSR39rep-ADP) with radiation therapy

Enrollment: 12 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with borderline resectable or locally advanced pancreatic cancer
• Patients with histologically confirmed pancreatic adenocarcinoma
• Patients with no evidence of peritoneal or hematogenous metastasis
• Patients with ECOG performance status 0-1
• 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 < 3 times upper limit of normal (ULN))
• Patients with agreement with informed consent

Exclusion criteria

• Patients with a history of other cancer
• Patients with recurred pancreatic cancer
• Patients with a history of radiation on more than 25% of bone marrow
• Patients with a history of major surgery except laparoscopic examination, endoscopic intervention, or gastrojejunostomy
• Patients who have contraindication of radiation therapy
• Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
• Female patients with childbearing age or pregnancy or breast feeding
• Patients who are considered as inappropriate candidate by investigators

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Theragene arm

Experimental group

Description:

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

Treatment:

Drug: Theragene arm