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

Neuroendocrine Tumors Clinical Trial

— EPICentro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02838342
• Other study ID #: API/2015/61
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2015
• Est. completion date: June 29, 2021

Study information

• Verified date: July 2021
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 29, 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Metronomic cyclophosphamide
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besancon
France	Hôpital Nord Franche-Comté	Montbéliard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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