NCT04129255

Octreotide LAR in the Induction of Immunologic Response in NENs Patients

IMMUNeOCT Study: Octreotide LAR in the Induction of Immunologic Response in Patient With Neuroendocrine Tumors: an Interventional Pharmacological Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the impact of OCTREOTIDE LAR on the immune response by studying Regulatory T-cell (T-Reg) and Myeloid-derived suppressor cells (MDSC) and the immunoregulatory cell population in peripheral blood of NET G1 / G2 patients treated with Octreotide LAR

Detailed description

MDSCs and T-Regs will be evaluated at baseline pre-treatment with octreotide, after 15 days, at three and at six months and before each octreotide LAR administration for 12 months. MDSC cells will be detected by surface receptors LIN-, CD11b, CD14, CD15, CD33, CD124-IL4-Ra, CD184-CXCR4, CD279-PD1, HLA-DR and T-reg cells from CD3, CD4, CD8 receptors , CD25, CD39, CD45RA, CD45R0, CD62L, CD127, CD152-CTLA-4, CD184-CXCR4, CD278-ICOS, CD279-PD-1. Briefly, CD4 + cells will be separated by negative selection, using the mixture of human CD4 antibodies. Octreotide is currently a registered drug to the FDA, EMA and AIFA with the indication for the treatment of well and moderately differentiated NETs functioning and not working on the front line. .

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Octreotide Acetate	administration every 28 days

Timeline

• Start date: 2017-06-28
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-10-16
• Last updated: 2020-09-10

Locations

1 site across 1 country: Italy