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

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ClinicalTrials.gov Identifier: NCT02838342
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date  ICMJE July 18, 2016
First Posted Date  ICMJE July 20, 2016
Last Update Posted Date December 24, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02838342 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Official Title  ICMJE Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE
  • Drug: Metronomic cyclophosphamide
    50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
    Other Name: 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 Name: IFN-alpha
Study Arms  ICMJE Experimental: Metronomic cyclophosphamide and interferon-alpha
Interventions:
  • Drug: Metronomic cyclophosphamide
  • Drug: Interferon-alpha
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2016)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stefano KIM, Dr stefanokim@me.com
Contact: Christophe BORG, Pr christophe.borg@efs.sante.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02838342
Other Study ID Numbers  ICMJE API/2015/61
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Besancon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP