Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy

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Study of Recombinant Adenovirus AdVince in Patients With Neuroendocrine Tumors; Safety and Efficacy

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject´s written informed consent. 2. Histologically and radiologically confirmed progressive neuroendocrine carcinoma of gastrointestinal, pancreatic or bronchial origin with multiple liver metastases. Progression in Clinical symptoms and tumor growth verified over the last 6 months on CT or MRI. 3. Cancer that is not considered resectable for potential cure or tumor reduction. 4. Patent portal vein and adequate liver perfusion. 5. Liver dominant disease with involvement of <60% of liver parenchyma. 6. Karnofsky performance status of >=70% 7. Life expectancy of >=6 months. 8. >=18 years of age. 9. Must use a reliable method of contraception if sexually active and of reproductive potential. 10. Plasma creatinine <105 ug/ml. 11. Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) <3.0-fold upper limit of normal. 12. Total bilirubin <2.0-fold upper limit of normal. 13. Prothrombin time (PT)/International Normalized Ratio (INR) <2.0 and Prothromboplastin time (PTT) within normal limits. 14. Neutrophils >1500/ml, hemoglobin >100 g/L, platelets >100 000/ml. 15. Patients with functioning NET should have cover by somatostatin analog.

Exclusion Criteria:

1. Known chronic liver dysfunction Before the development of metastatic cancer (e.g. cirrhosis, chronic hepatitis) 2. Active infection, including documented HIV and hepatitis C. 3. Any viral syndrome diagnosed within the previous 2 weeks. 4. Chemotherapy within the previous 4 weeks Before the first treatment. 5. Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan. 6. Concomitant malignancy. 7. Pregnant or lactating females. 8. Prior participation in any research protocol that involved administration of adenovirus vectors. 9. Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease. 10. Continuing treatment with any other cancer therapy

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02749331
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Uppsala University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joakim Crona, MD, PhD
Principal Investigator Affiliation	Uppsala University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Sweden
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors

Additional Details

An open-labelled, uncontrolled, single-center Phase I/IIa clinical study to evaluate the safety of repeated infusions of AdVince into the hepatic artery in patients with metastatic neuroendocrine tumors (NETs), and if possible determination of maximum tolerated dose. Secondary objectives include to evaluate the anti-tumoral efficacy of AdVince infusions on metastatic neuroendocrine tumors, to determine the replication profile of AdVince and to determine the humoral (antibody) and cytokine-mediated immune response to AdVince. Minimum 12 and maximum 35 patients will be included, the number is based on the toxicity observed.

Arms & Interventions

Arms

Experimental: AdVince

Dose escalation, minimum 3 patients per dose in Phase I. Dose levels: 1. 10 000 000 000 virus particles 2. 100 000 000 000 virus particles 3. 300 000 000 000 virus particles 4. 1000 000 000 000 virus particles Maximum tolerated dose will be confirmed by 12 additional patients treated at this dose level in Phase IIa.

Interventions

Drug: - AdVince

Virus solution for infusion in intrahepatic artery

Contact a Trial Team

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International Sites

Uppsala, Sweden

Status

Address

Endocrine Oncology Clinic, Uppsala University Hospital

Uppsala, , 752 37

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