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Clinical Trial Record

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Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer

2015-12

2018-05

2018-05

7

Study Overview

Parvovirus H-1 (ParvOryx) in Patients With Metastatic Inoperable Pancreatic Cancer

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.

  • Carcinoma, Pancreatic Ductal
  • DRUG: Parvovirus H-1 (H-1PV)
  • ParvOryx02

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2015-12-04  

N/A  

2022-11-16  

2016-01-08  

N/A  

2022-11-21  

2016-01-12  

N/A  

2019-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: ParvOryx

ParvOryx given intravenously on four consecutive days (day 1 to 4) and intrametastatic six to thirteen days thereafter (day 7, 10 or 14).

DRUG: Parvovirus H-1 (H-1PV)

  • 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 m
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety and tolerability of the IMPParameter: findings in physical examinationsUp to 6 months after treatment beginning
Safety and tolerability of the IMPParameters: chosen laboratory parametersUp to 6 months after treatment beginning
Safety and tolerability of the IMPParameter: ECGUp to 6 months after treatment beginning
Safety and tolerability of the IMPParameter: adverse eventsUp to 6 months after treatment beginning
Humoral immuneresponse to the IMPParameter: Serum concentration of anti-drug antibodies (ADA)Up to 6 months after treatment beginning
Pharmacokinetics of viral genomes [Vg]Parameter: Cmax in bloodUp to 6 months after treatment beginning
Pharmacokinetics of viral genomes [Vg]Parameter: AUC in bloodUp to 6 months after treatment beginning
Shedding of viral genomes [Vg]Parameter: Concentration of Vg in feacesUp to 6 months after treatment beginning
Shedding of viral genomes [Vg]Parameter: Concentration of Vg in urineUp to 6 months after treatment beginning
Shedding of viral genomes [Vg]Parameter: Concentration of Vg in salivaUp to 6 months after treatment beginning
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Histo-immuno-pathological effects of the IMP in the hepatic metastasisParameter: extent of tumor necrosisUp to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasisParameter: density of tumor infiltrating cellsUp to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasisParameter: tissue content of cytokinesUp to 2 months after treatment beginning
Histo-immuno-pathological effects of the IMP in the hepatic metastasisParameter: tissue content of chemokinesUp to 2 months after treatment beginning
Extent of virus replication in the hepatic metastasisParameters: quantification of NS-1 protein in the metastatic tissueUp to 2 months after treatment beginning
Cellular immune response against viral proteinsParameter: ELISPOTUp to 6 months after treatment beginning
Cellular immune response against viral proteinsParameter: FACSUp to 6 months after treatment beginning
Clinical outcomeParameters: PFS, OSUp to 6 months after treatment beginning
Clinical outcomeParameter: Serum concentration of CA19-9Up to 6 months after treatment beginning

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Age at least 18 year, 2. Ability to give informed consent, 3. Histologically confirmed pancreatic ductal adenocarcinoma (PAD) with at least one measurable hepatic metastasis according to RECIST 1.1, 4. Disease progression despite first line therapy (whatever chemotherapy regimen), 5. Eligibility for second line chemotherapy with gemcitabine, 6. ECOG performance scale 0 or 1, 7. Consent for the sampling and investigations of biological specimens as scheduled by the trial protocol, 8. Adequate bone marrow function: neutrophils >1.5 x 1E09/L, platelets >100 x 1E09/L, hemoglobin >9.0 g/dL, 9. Liver function tests (LFT) within the following range: Bilirubin <3 x ULN (Upper Limit of Normal); ASAT and ALAT <5 x ULN, 10. Adequate renal function: Creatinine <1.5 g/dL, 11. Adequate blood clotting: aPTT <39 sec, INR <1.2, 12. Normal thyroid function, i.e. TSH, fT3 and fT4 within the normal range (TSH: 0.4 - 4.0 mU/l, fT3: 2.0 - 4.2 ng/l, fT4: 8 - 18 ng/l) 13. Negative serology for HIV, HBV and HCV, 14. Negative Beta-HCG test in blood in woman of childbearing potential, 15. Use of adequate contraception in both genders, i.e. use of double-effective method of contraception for the entire participation in the trial.
    Exclusion Criteria:
    1. Eligibility for surgical treatment, 2. Symptomatic cerebral, pulmonal, and/or osseous metastases, 3. Peritoneal carcinosis, 4. Liver cirrhosis, 5. Splenectomy, 6. Relevant respiratory impairment, corresponding to the grade IV or V of the MRC Breathlessness Scale (stops for breath after walking about 100 meters or after a few minutes on level ground, or too breathless to leave the house, or breathless when undressing), 7. Positive anti-drug antibodies (ADAs) against ParvOryx, 8. Hospitalization due to other conditions than the pancreatic cancer within the last 3 months, 9. Chemotherapy within 2 weeks prior to the first administration of the IMP, 10. Signs of active, systemic infection within 7 days prior to the study inclusion (clinical symptoms (cough, running nose, burning sensation while urinating, apparent skin or wound infection) and/or increase of fever and/or deterioration of infection-specific laboratory parameters beyond changes apparently driven by the underlying pancreatic cancer), 11. Radiotherapy within 6 weeks prior to the study inclusion, 12. Contraindications for CT, 13. Known allergy to iodinated contrast media, 14. Participation in another interventional trial within the last 30 days, 15. Presumed contact with pregnant women and/or infants <12 months of age within two months after the first administration of the IMP.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_DIRECTOR: Bernard Huber, Dr., Oryx GmbH & Co. KG

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Hajda J, Lehmann M, Krebs O, Kieser M, Geletneky K, Jager D, Dahm M, Huber B, Schoning T, Sedlaczek O, Stenzinger A, Halama N, Daniel V, Leuchs B, Angelova A, Rommelaere J, Engeland CE, Springfeld C, Ungerechts G. A non-controlled, single arm, open label, phase II study of intravenous and intratumoral administration of ParvOryx in patients with metastatic, inoperable pancreatic cancer: ParvOryx02 protocol. BMC Cancer. 2017 Aug 29;17(1):576. doi: 10.1186/s12885-017-3604-y.
    • Hajda J, Leuchs B, Angelova AL, Frehtman V, Rommelaere J, Mertens M, Pilz M, Kieser M, Krebs O, Dahm M, Huber B, Engeland CE, Mavratzas A, Hohmann N, Schreiber J, Jager D, Halama N, Sedlaczek O, Gaida MM, Daniel V, Springfeld C, Ungerechts G. Phase 2 Trial of Oncolytic H-1 Parvovirus Therapy Shows Safety and Signs of Immune System Activation in Patients With Metastatic Pancreatic Ductal Adenocarcinoma. Clin Cancer Res. 2021 Oct 15;27(20):5546-5556. doi: 10.1158/1078-0432.CCR-21-1020. Epub 2021 Aug 23.
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