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

July 30, 2021 updated by: Centre Hospitalier Universitaire de Besancon
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France
        • Centre Hospitalier Universitaire de Besançon
      • Montbéliard, France
        • Hôpital Nord Franche-Comté

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at 3 months of the association CMC and Interferon-alpha

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2015

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 29, 2021

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2015/61

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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