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Trial record 75 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

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

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: Metronomic cyclophosphamide Drug: Interferon-alpha Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Study Start Date : May 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019


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 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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838342


Contacts
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Contact: Stefano KIM, Dr stefanokim@me.com
Contact: Christophe BORG, Pr christophe.borg@efs.sante.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besancon, France
Contact: Stefano KIM, Dr       stefanokim@me.com   
Principal Investigator: Stefano KIM, Dr         
Hôpital Nord Franche-Comté Recruiting
Montbéliard, France
Contact: Stefano KIM, Dr       stefanokim@me.com   
Principal Investigator: Stefano KIM, Dr         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02838342     History of Changes
Other Study ID Numbers: API/2015/61
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Cyclophosphamide
Interferons
Interferon alpha-2
Interferon-alpha
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antiviral Agents
Anti-Infective Agents