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

Phase 2

Completed

• Conditions: Neuroendocrine Tumors
• Interventions: Drug: Metronomic cyclophosphamide; Drug: Interferon-alpha

• Registration Number: NCT02838342
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-19
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Primary Completion: 2020-04
• Study Completion: 2021-06-29
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metronomic cyclophosphamide and interferon-alpha	Interferon-alpha	-
Metronomic cyclophosphamide and interferon-alpha	Metronomic cyclophosphamide	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Centre Hospitalier Universitaire de Besançon; 🇫🇷 Besancon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France