Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors (EPICentro)
Primary Purpose
Neuroendocrine Tumors
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Metronomic cyclophosphamide
Interferon-alpha
Sponsored by
About this trial
This is an interventional other trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- performance status ECOG-WHO ≤ 1
- histologically proved neuroendocrine tumor with Ki67 < or = 10%, metastatic or locally advanced without surgery possibility
- at least one measurable lesion based on RECIST criteria version 1.1
- signed written informed consent
Exclusion Criteria:
- previous treatment with interferon or cyclophosphamide
- treatment by immunosuppressive drugs
- diabetes complicated by coronary artery disease or vasculopathy
- severe respiratory failure, chronic respiratory failure, COPD
- history of severe heart failure
- severe renal or hepatic impairment
- diabetes complicated with coronary artery disease or vasculopathy
- alcoholism unweaned
- uncontrolled epilepsy and/or achievement of the central nervous system functions
- history of severe depressive syndrome
- presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
- decompensated liver cirrhosis
- severe myelosuppression
- psoriasis and sarcoidosis
- active disease condition or uncontrolled infection
- association with the yellow fever vaccine
- association with phenytoin in prophylaxis
- hypersensitivity against interferon or cyclophosphamide
- prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years
- pregnancy, breast-feeding or absence of adequate contraception for fertile patients
- patients under guardianship, curatorship or under the protection of justice
Sites / Locations
- Centre Hospitalier Universitaire de Besançon
- Hôpital Nord Franche-Comté
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metronomic cyclophosphamide and interferon-alpha
Arm Description
Outcomes
Primary Outcome Measures
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
Secondary Outcome Measures
Full Information
NCT ID
NCT02838342
First Posted
July 18, 2016
Last Updated
July 30, 2021
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02838342
Brief Title
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Acronym
EPICentro
Official Title
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 19, 2015 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
June 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metronomic cyclophosphamide and interferon-alpha
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metronomic cyclophosphamide
Other Intervention Name(s)
CMC
Intervention Description
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
Intervention Type
Drug
Intervention Name(s)
Interferon-alpha
Other Intervention Name(s)
IFN-alpha
Intervention Description
3 months of treatment from the 4th cycle metronomic cyclophosphamide : subcutaneous injection, initial dose of 3 MIU three times a week. The dose may be adjusted as tolerated to achieve a T cell counts greater than 500 / mm3
Primary Outcome Measure Information:
Title
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
Time Frame
at 3 months of the association CMC and Interferon-alpha
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
performance status ECOG-WHO ≤ 1
histologically proved neuroendocrine tumor with Ki67 < or = 10%, metastatic or locally advanced without surgery possibility
at least one measurable lesion based on RECIST criteria version 1.1
signed written informed consent
Exclusion Criteria:
previous treatment with interferon or cyclophosphamide
treatment by immunosuppressive drugs
diabetes complicated by coronary artery disease or vasculopathy
severe respiratory failure, chronic respiratory failure, COPD
history of severe heart failure
severe renal or hepatic impairment
diabetes complicated with coronary artery disease or vasculopathy
alcoholism unweaned
uncontrolled epilepsy and/or achievement of the central nervous system functions
history of severe depressive syndrome
presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
decompensated liver cirrhosis
severe myelosuppression
psoriasis and sarcoidosis
active disease condition or uncontrolled infection
association with the yellow fever vaccine
association with phenytoin in prophylaxis
hypersensitivity against interferon or cyclophosphamide
prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years
pregnancy, breast-feeding or absence of adequate contraception for fertile patients
patients under guardianship, curatorship or under the protection of justice
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Besançon
City
Besancon
Country
France
Facility Name
Hôpital Nord Franche-Comté
City
Montbéliard
Country
France
12. IPD Sharing Statement
Learn more about this trial
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
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