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

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

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Key information

Conditions

Neuroendocrine Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire de Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metronomic cyclophosphamide

Drug

50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance

Other names: CMC

Interferon-alpha

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: EPICentro

Important dates

Study start: 2015
Primary completion: 2020
Study completion: 2021
First posted: Jul 20, 2016
Registry last updated: Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed