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

  • STATUS
    Recruiting
  • End date
    Sep 10, 2024
  • participants needed
    35
  • sponsor
    Uppsala University
Updated on 23 February 2022
cancer
carcinoma
somatostatin
international normalized ratio
metastasis
neutrophil count
liver metastasis
neuroendocrine carcinoma

Summary

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.

Description

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.

Details
Condition Neuroendocrine Tumors
Treatment AdVince
Clinical Study IdentifierNCT02749331
SponsorUppsala University
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects written informed consent
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
Cancer that is not considered resectable for potential cure or tumor reduction
Patent portal vein and adequate liver perfusion
Liver dominant disease with involvement of <60% of liver parenchyma
Karnofsky performance status of >=70%
Life expectancy of >=6 months
>=18 years of age
Must use a reliable method of contraception if sexually active and of reproductive potential
Plasma creatinine <105 ug/ml
Aspartate transaminase (AST), Alanine transaminase (ALT) and Alkaline Phosphatase (ALP) <3.0-fold upper limit of normal
Total bilirubin <2.0-fold upper limit of normal
Prothrombin time (PT)/International Normalized Ratio (INR) <2.0 and Prothromboplastin time (PTT) within normal limits
Neutrophils >1500/ml, hemoglobin >100 g/L, platelets >100 000/ml
Patients with functioning NET should have cover by somatostatin analog

Exclusion Criteria

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

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