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

Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
CT.gov ID

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:
Actual Enrollment :
28 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
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


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    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


    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


    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    Centre Hospitalier Universitaire de Besancon
    ClinicalTrials.gov Identifier:
    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