Clinical trial NCT02894944: Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Adenovirus
Gene therapy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: NewGenPharm Inc.
First posted: 2016-09-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events assessed by CTCAE v4.03
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events assessed by CTCAE v4.03
timeFrame: 12 weeks
measure: Tumor response
timeFrame: 8 weeks
measure: Time to disease progression
timeFrame: 6.5 months
measure: Detection of Infected Adenovirus in blood and urine assessed by PCR
timeFrame: 8 weeks
measure: Detection of adenoviral DNA in blood by PCR
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Lee JC, Shin DW, Park H, Kim J, Youn Y, Kim JH, Kim J, Hwang JH. Tolerability and safety of EUS-injected adenovirus-mediated double-suicide gene therapy with chemotherapy in locally advanced pancreatic cancer: a phase 1 trial. Gastrointest Endosc. 2020 Nov;92(5):1044-1052.e1. doi: 10.1016/j.gie.2020.02.012. Epub 2020 Feb 19.