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

Pancreatic Cancer Clinical Trial

— Theragene  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894944
• Other study ID #: SNUBH-IMGPB-2016-02
• Status: Completed
• Phase: Phase 1
• Start date: August 2016
• Est. completion date: April 2019

Study information

• Verified date: August 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: April 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	NewGenPharm Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events assessed by CTCAE v4.03		8 weeks
Secondary	Number of participants with treatment-related adverse events assessed by CTCAE v4.03		12 weeks
Secondary	Tumor response		8 weeks
Secondary	Time to disease progression		6.5 months
Secondary	Detection of Infected Adenovirus in blood and urine assessed by PCR		8 weeks
Secondary	Detection of adenoviral DNA in blood by PCR		8 weeks