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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University

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