Back to resultsOctreotide LAR in the Induction of Immunologic Response in NENs Patients (CSMS99)
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Octreotide Acetate
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Octreotide, neuroendocrine tumors, immunological response
Eligibility 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
Sites / Locations
- Istitute Nazionale Tumori - Fondazione G. Pascale
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)
Arm Description
OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
safety assessment
Safety profile according to CTCAE criteria
Full Information
NCT ID
NCT04129255
First Posted
August 27, 2019
Last Updated
September 9, 2020
Sponsor
National Cancer Institute, Naples
1. Study Identification
Unique Protocol Identification Number
NCT04129255
Brief Title
Octreotide LAR in the Induction of Immunologic Response in NENs Patients
Acronym
CSMS99
Official Title
IMMUNeOCT Study: Octreotide LAR in the Induction of Immunologic Response in Patient With Neuroendocrine Tumors: an Interventional Pharmacological Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Naples
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
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. .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Octreotide, neuroendocrine tumors, immunological response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OCTREOTIDE LONG-ACTING RELEASE (OCT LAR)
Arm Type
Other
Arm Description
OCT LAR is already registered By FDA for USA, by EMA for Europe and , also, by AIFA for Italy.
Intervention Type
Drug
Intervention Name(s)
Octreotide Acetate
Other Intervention Name(s)
Somatostatin analog
Intervention Description
administration every 28 days
Primary Outcome Measure Information:
Title
Exploring the changes in immune-regulatory cells induced by OCT LAR
Description
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
Secondary Outcome Measure Information:
Title
Outcome
Description
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)
Title
safety assessment
Description
Safety profile according to CTCAE criteria
Time Frame
1 month (safety)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salvatore Tafuto, MD
Organizational Affiliation
NCI Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istitute Nazionale Tumori - Fondazione G. Pascale
City
Napoli
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Octreotide LAR in the Induction of Immunologic Response in NENs Patients
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