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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02838342
Other study ID # API/2015/61
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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