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Trial record 11 of 53 for:    somatostatin analogues | Neuroendocrine Tumors

Octreotide LAR in the Induction of Immunologic Response in NENs Patients (CSMS99)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129255
Recruitment Status : Active, not recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Salvatore Tafuto, National Cancer Institute, Naples

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Octreotide Acetate Phase 2

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. .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IMMUNeOCT Study: Octreotide LAR in the Induction of Immunologic Response in Patient With Neuroendocrine Tumors: an Interventional Pharmacological Study
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)
OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.
Drug: Octreotide Acetate
administration every 28 days
Other Name: Somatostatin analog




Primary Outcome Measures :
  1. Exploring the changes in immune-regulatory cells induced by OCT LAR [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Outcome [ Time Frame: 3 months (PFS - ORR) ]

    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)


  2. safety assessment [ Time Frame: 1 month (safety) ]
    Safety profile according to CTCAE criteria



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129255


Locations
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Italy
Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
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Principal Investigator: Salvatore Tafuto, MD NCI Naples
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Responsible Party: Salvatore Tafuto, MEDICAL DOCTOR, National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT04129255    
Other Study ID Numbers: IMMUNeOCT
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Salvatore Tafuto, National Cancer Institute, Naples:
Octreotide
neuroendocrine tumors
immunological response
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Somatostatin
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs