Octreotide LAR in the Induction of Immunologic Response in NENs Patients

NCT04129255 | Completed Phase 2

• 1 other identifier: IMMUNeOCT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Neuroendocrine Tumors

Keywords

Octreotide; neuroendocrine tumors; immunological response

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Outcome

  3 months (PFS - ORR)

• safety assessment

  1 month (safety)

Study Arms (1)

OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)

OTHER

OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.

Drug: Octreotide Acetate

Interventions

Octreotide Acetate DRUG

administration every 28 days

Also known as: Somatostatin analog

OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patients awareness and willingness to comply with the study requirements.
• Patients ≥18 years of age.
• Patients with histologically confirmed well and moderately differentiated Neuroendocrine Tumors with Ki67 ≤ 20% (Ki67 must be quantified in percentage) and candidates for treatment with octreotide.
• ECOG performance status (PS) of 0-2.
• At least 28 days since prior the last radiation therapy or surgery.
• Estimated life expectancy of ≥12 weeks.

You may not qualify if:

• Patients \< 18 years of age.
• According to the current SmPC of the prescribed drug agent.
• Previuos treatment with octreotide.
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
• Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
• Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
• Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as inferior to 2 years after last menstruation and not surgically sterile) not using effective, non hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
• Patients with meningeal carcinomatosis
• Patients with known positive HIV status

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (1)

Istitute Nazionale Tumori - Fondazione G. Pascale

Napoli, Italy

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Octreotide; Somatostatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Salvatore Tafuto, MD

  NCI Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MEDICAL DOCTOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: October 16, 2019
• Study Start: June 28, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)