Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis.
Investigation on safety, tolerability and efficacy of parvovirus H-1 (ParvOryx) in subjects suffering from metastatic, inoperable pancreatic cancer with at least one hepatic metastasis. Initially four equal doses of ParvOryx will be administered intravenously on four consecutive days. Seven to fourteen days after the first intravenous administration the drug will be injected directly in a hepatic metastasis of the pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer. The total dose levels are: 1E09, 5E09 and 1E10 pfu.
National Center for Tumor Diseases (NCT)
Heidelberg, Baden-Wurttemberg, Germany
Safety and tolerability of the IMP
Parameter: findings in physical examinations
Time frame: Up to 6 months after treatment beginning
Safety and tolerability of the IMP
Parameters: chosen laboratory parameters
Time frame: Up to 6 months after treatment beginning
Safety and tolerability of the IMP
Parameter: ECG
Time frame: Up to 6 months after treatment beginning
Safety and tolerability of the IMP
Parameter: adverse events
Time frame: Up to 6 months after treatment beginning
Humoral immuneresponse to the IMP
Parameter: Serum concentration of anti-drug antibodies (ADA)
Time frame: Up to 6 months after treatment beginning
Pharmacokinetics of viral genomes [Vg]
Parameter: Cmax in blood
Time frame: Up to 6 months after treatment beginning
Pharmacokinetics of viral genomes [Vg]
Parameter: AUC in blood
Time frame: Up to 6 months after treatment beginning
Shedding of viral genomes [Vg]
Parameter: Concentration of Vg in feaces
Time frame: Up to 6 months after treatment beginning
Shedding of viral genomes [Vg]
Parameter: Concentration of Vg in urine
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Time frame: Up to 6 months after treatment beginning
Shedding of viral genomes [Vg]
Parameter: Concentration of Vg in saliva
Time frame: Up to 6 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasis
Parameter: extent of tumor necrosis
Time frame: Up to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasis
Parameter: density of tumor infiltrating cells
Time frame: Up to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasis
Parameter: tissue content of cytokines
Time frame: Up to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasis
Parameter: tissue content of chemokines
Time frame: Up to 2 months after treatment beginning
Extent of virus replication in the hepatic metastasis
Parameters: quantification of NS-1 protein in the metastatic tissue
Time frame: Up to 2 months after treatment beginning
Cellular immune response against viral proteins
Parameter: ELISPOT
Time frame: Up to 6 months after treatment beginning
Cellular immune response against viral proteins
Parameter: FACS
Time frame: Up to 6 months after treatment beginning
Clinical outcome
Parameters: PFS, OS
Time frame: Up to 6 months after treatment beginning
Clinical outcome
Parameter: Serum concentration of CA19-9
Time frame: Up to 6 months after treatment beginning