Clinical Trial Phase I for Theragene in Combination With Chemotherapy for the Locally Advanced Pancreatic Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Theragene arm Patients who were treated with Theragene®,Ad5-yCD/mutTKSR39rep-ADP and chemotherapy |
Biological: Theragene®,Ad5-yCD/mutTKSR39rep-ADP
Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03 [8 weeks]
Secondary Outcome Measures
- Number of participants with treatment-related adverse events assessed by CTCAE v4.03 [12 weeks]
- Tumor response [8 weeks]
- Time to disease progression [6.5 months]
- Detection of Infected Adenovirus in blood and urine assessed by PCR [8 weeks]
- Detection of adenoviral DNA in blood by PCR [8 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with pancreatic cancer stage 3
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Patients with histologically confirmed pancreatic adenocarcinoma
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Patients with no evidence of peritoneal or hematogenous metastasis
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Patients with ECOG performance status 0-2
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Patients with renal function (Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min/m²)
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Patients with bone marrow function (WBC > 4,000/uL or absolute neutrophil count ≥ 1500/uL, PLT ≥ 100,000/uL, and Hemoglobin > 10 g/dL)
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Patients with liver function (Bilirubin < 2.0 mg/dL and SGOT and SGPT < 2.5 times upper limit of normal (ULN))
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Patients with agreement with informed consent
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Male patients with contraception
Exclusion Criteria:
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Female patients with childbearing age or pregnancy or breast feeding
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Patients with a history of chemotherapy within 5 years
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Patients with a history of radiation on more than 25% of bone marrow
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Patients with unknown stage or recurrent pancreatic cancer
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Patients with a history of skin cancer except malignant melanoma or malignancy except stage 0 cervical cancer
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Patients with a history of major surgery except laparoscopic exam, endoscopic ultrasound, stenting, or PEG/PEJ placement
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Patients with active or uncontrolled infection
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Patients with immunosuppression or susceptibility to viral infection
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Patients with HIV infection, chronic hepatitis B, chronic hepatitis C, or liver cirrhosis
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Patients with a history of allergy to clinical trial medications
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Patients who are considered as inappropriate candidate by investigators
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bundang Hospital | Seongnam | Gyeonggi-do | Korea, Republic of | 463-707 |
Sponsors and Collaborators
- Seoul National University Hospital
- NewGenPharm Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUBH-IMGPB-2016-02