NCT02838342

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 19, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2021

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2021

Enrollment Period

4.9 years

First QC Date

July 18, 2016

Last Update Submit

July 30, 2021

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (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

Study Arms (1)

Metronomic cyclophosphamide and interferon-alpha

EXPERIMENTAL
Drug: Metronomic cyclophosphamideDrug: Interferon-alpha

Interventions

Metronomic cyclophosphamideDRUG

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

Also known as: CMC
Metronomic cyclophosphamide and interferon-alpha
Interferon-alphaDRUG

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

Also known as: IFN-alpha
Metronomic cyclophosphamide and interferon-alpha

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Universitaire de Besançon

Besançon, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

May 19, 2015

Primary Completion

April 1, 2020

Study Completion

June 29, 2021

Last Updated

August 2, 2021

Record last verified: 2021-07

Locations

FR(2)