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
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. .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
administration every 28 days
Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, Italy
Exploring the changes in immune-regulatory cells induced by OCT LAR
The primary objective of the project is to evaluate changes in immune-regulatory cells induced by OCT LAR from baseline to month 6. Therefore, we will observe the impact of OCTREOTIDE LAR on the immune response by studying T-Reg and MDSC and the immunoregulatory cell population in peripheral blood of patients with neuroendocrine tumors G1 / G2 treated with OCT LAR.
Time frame: 6 months
Outcome
Objective response rate according to RECIST. Progression-free survival (PFS), defined as the time (days) from start date of octreotide to date of first documented disease progression or death due to any cause, if death occurs before progression is documented. Progression-free survival as the time (days) from start date of OCT to date of first PD or death due to any cause; Safety :number of patients presenting AE during treatment and observation period (CTCAE v.4)
Time frame: 3 months (PFS - ORR)
safety assessment
Safety profile according to CTCAE criteria
Time frame: 1 month (safety)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.