EPICentro: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT02838342
Collaborator
(none)
28
2
1
73.4
14
0.2

Study Details

Study Description

Brief Summary

This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Actual Study Start Date :
May 19, 2015
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Jun 29, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metronomic cyclophosphamide and interferon-alpha

Drug: Metronomic cyclophosphamide
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
Other Names:
  • CMC
  • Drug: Interferon-alpha
    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
    Other Names:
  • IFN-alpha
  • Outcome Measures

    Primary Outcome Measures

    1. rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique" [at 3 months of the association CMC and Interferon-alpha]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Universitaire de Besançon Besancon France
    2 Hôpital Nord Franche-Comté Montbéliard France

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire de Besancon

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    NCT02838342
    Other Study ID Numbers:
    • API/2015/61
    First Posted:
    Jul 20, 2016
    Last Update Posted:
    Aug 2, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    No Results Posted as of Aug 2, 2021