Status:
COMPLETED
Octreotide LAR in the Induction of Immunologic Response in NENs Patients
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04129255
Start Date
June 28 2017
End Date
December 1 2019
Last Update
September 10 2020
Active Locations (1)
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1
Istitute Nazionale Tumori - Fondazione G. Pascale
Napoli, Italy