Treatment of neuroendocrine neoplasms with genetically modified adenovirus

Phase 1

• Conditions: euroendocrine neoplasms (NENs) is a heterogeneous group with varying symptoms, tumor biology and treatment response. NENs may occur in any organ, most commonly they are observed in the gastroenteropancreatic system and lungs. Most NEN patients are diagnosed at advanced stage, 65% of them will die within 5 years. The only curative treatment is surgery with complete resection of the primary tumor. However, more than 50% of patients exhibit metastatic disease, where there is no cure.; MedDRA version: 20.0Level: PTClassification code 10071542Term: Neuroendocrine carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000614-64-SE
• Lead Sponsor: Department of Immunology, Genetics and Pathology (IGP), Rudbeck Laboratory, Uppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-27
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Subject's written informed consent
2. Histologically confirmed NEN of gastrointestinal, pancreatic or bronchial origin
3. Disease progression verified over the last 6 months on CT or MRI using criteria employed in standard practice at the local hospital
4. Disease that is not considered resectable for potential cure or tumor reduction
5. Standard anti-cancer therapy exhausted according to the European Society of Medical Oncology (ESMO) guidelines for GEP-NETs and according to the European Neuroendocrine Tumor Society (ENETS) guidelines for lung carcinoids
6. Adequate liver perfusion ensured e.g. by patent portal vein, patent hepatic veins
7. Liver dominant disease with involvement of < 60% of liver parenchyma
8. Karnofsky performance status of =70%
9. Life expectancy of = 6 months
10. = 18 years of age
11. Must use a reliable method of contraception if sexually active and of reproductive potential*
12. Plasma creatinine < 105 µg/ml
13. AST, ALT < 5.0-fold upper limit of normal
14. Total bilirubin < 3.0-fold upper limit of normal
15. PT/INR < 2.0 and PTT within normal limits
16. Neutrophils > 1,500/µl, haemoglobin > 100 g/L, platelets > 100,000/µl
17. Patients with functioning NEN should have cover by somatostatin analog

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

18. Known chronic liver dysfunction before the development of metastatic cancer (e.g., cirrhosis, chronic hepatitis)
19. Active infection, including documented HIV and hepatitis C
20. Any viral syndrome diagnosed within the previous 2 weeks
21. Systemic anti-cancer therapy (except for somatostatin analogues) within the previous 4 weeks before the first treatment
22. Radiotherapy to the target tumor site within the last 24 weeks from the baseline CT scan.
23. Evidence of clinically significant immunosuppression such as primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
24. Requirement of treatment with corticosteroids (prednisone >10 mg/day or equivalent)
25. Concomitant malignancy
26. Pregnant or lactating females
27. Prior participation in any research protocol that involved administration of adenovirus vectors
28. Treatment with any other investigational therapy within the last 4 weeks, organ transplantation prior to treatment, severe cardiovascular, metabolic or pulmonary disease
29. Continuing treatment with any other cancer therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified